[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bladder-urothelial-transitional-cell-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bladder-urothelial-transitional-cell-cancer":679},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,58,85,116,143,170,204,227,255,274,303,330,353,384,408,433,461,485,517,544,565,579,604,630,654],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100597545",false,"NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-","ALL","18 Years",{"count":19,"type":20},104,"ESTIMATED","INTERVENTIONAL",[23],"NA","This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Breast Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gall Bladder Cancer","Gastric Cancer","Kidney Cancer","Liver Cancer","Lung Cancer","Head and Neck Cancer","Ovarian Cancer","Pancreatic Cancer","Prostate Cancer","Rectal Cancer","Sarcoma","RECRUITING","2026-07-01",{"date":48,"type":49},"2026-07-02","ACTUAL",{"date":51,"type":49},"2026-02-11",{"date":53,"type":20},"2027-08-31",{"name":55,"class":56},"Alliance for Clinical Trials in Oncology","OTHER",18,{"id":59,"slug":4,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":70,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100602168","NCT07119996","Clinical Trial on the Protective Role of Vitamin B3 in Enhancing Immunotherapy for Bladder Cancer Patients","A Phase Ib Study Evaluating the Safety and Efficacy of Vitamin B3 Combined With Neoadjuvant Tislelizumab Plus Gemcitabine\u002FCisplatin in Antibiotic-Exposed Patients With cT2-T4aN0M0 Urothelial Carcinoma of the Bladder","Inclusion Criteria\n\n1. The patient voluntarily agrees to participate, is able to provide written informed consent, and is willing and able to comply with the protocol and schedule of assessments.\n2. Aged ≥18 years on the date of signing the informed-consent form (ICF).\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 1).\n4. Residual tumour after TURBT and histologically confirmed urothelial carcinoma of the bladder staged cT2-T4a N0 M0 by AJCC 8th edition imaging; for mixed-histology tumours, the urothelial component must be predominant (≥50 %).\n5. An infection occurring from 30 days to 1 day before the first dose of immuno-chemotherapy that, in the judgement of the attending physician, required oral or intravenous bactericidal antibiotics and met any of the following diagnostic criteria:\n\n   1. Clinical features (e.g. ≥38.3 °C or sustained ≥38 °C for ≥1 h with chills, local pain, dysuria, etc.) plus laboratory evidence (WBC \\> 10 × 10⁹\u002FL or \\\u003C 4 × 10⁹\u002FL, neutrophilia \u002F neutropenia, markedly elevated CRP) consistent with bacterial infection;\n   2. Abnormal urinalysis suggestive of urinary-tract infection (e.g. WBC \\> 10\u002FHPF, bacteria seen on high-power field, nitrite positive) with pathogen confirmed by urine culture;\n   3. Infection confirmed by imaging or other microbiological tests (e.g. blood culture, nasopharyngeal swab, sputum culture).\n\n   Permitted bactericidal antibiotics (oral or IV) include but are not limited to:\n   1. β-lactams (penicillins, cephalosporins, carbapenems);\n   2. Glycopeptides (vancomycin, teicoplanin);\n   3. Quinolones (levofloxacin, ciprofloxacin);\n   4. Aminoglycosides (gentamicin, streptomycin).\n6. Adequate organ function, documented within ≤14 days before enrolment:\n\n   a. No growth-factor support ≤14 days before sampling and: i. Absolute neutrophil count ≥1.5 × 10⁹\u002FL; ii. Platelets ≥90 × 10⁹\u002FL; iii. Haemoglobin ≥90 g\u002FL; b. INR or aPTT ≤1.5 × ULN; c. Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome or isolated indirect hyper-bilirubinaemia of extra-hepatic origin); d. AST, ALT and alkaline phosphatase ≤2.5 × ULN; e. Pulmonary function adequate to tolerate major abdominal surgery.\n7. Considered cisplatin-eligible by the investigator. Patients deemed cisplatin-ineligible must meet ≥1 of: ECOG \\> 1 or Karnofsky 60-70 %; creatinine clearance \\\u003C 60 mL\u002Fmin; NCI-CTCAE v5.0 grade ≥2 hearing loss; NCI-CTCAE v5.0 grade ≥2 peripheral neuropathy; New York Heart Association class III or IV heart failure.\n8. Women of child-bearing potential agree to use highly effective contraception during the study and for ≥120 days after the last dose of tislelizumab or chemotherapy (whichever is later) and have a negative urine or serum pregnancy test ≤7 days before enrolment. Non-sterilised men likewise agree to use highly effective contraception for the same period (Appendix 5).\n\nExclusion Criteria\n\nPatients meeting any of the following are ineligible:\n\n1. Previous therapy directed against PD-1, PD-L1, PD-L2, CTLA-4 or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.\n2. Systemic anticancer therapy or systemic immunomodulator (e.g. interferon, interleukin-2, TNF) within 28 days before enrolment.\n3. Prior radiotherapy to the bladder.\n4. Prior antitumour drug therapy, except:\n\n   1. ≥12 months since the last dose of systemic chemotherapy before study neoadjuvant therapy;\n   2. Intravesical chemotherapy or immunotherapy completed ≥1 week before study treatment.\n5. Major surgery or significant trauma within 28 days before enrolment (vascular-access placement and TURBT are not major surgery).\n6. Live vaccine within 28 days before enrolment (inactivated seasonal influenza vaccine is permitted; intranasal influenza vaccine is live and prohibited).\n7. Active autoimmune disease requiring systemic therapy that, in the investigator's opinion, would interfere with study treatment.\n8. Long-term high-dose corticosteroids or other immunosuppressants that, in the investigator's opinion, would interfere with study treatment.\n9. Clinically significant abnormalities that could affect treatment, including electrolyte disturbance (K, Na, Ca), hypoalbuminaemia, interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases (e.g. diabetes, hypertension, cardiovascular disease such as severe\u002Funstable angina, myocardial infarction, symptomatic congestive heart failure, or clinically significant ventricular arrhythmia within 6 months).\n10. Untreated chronic HBV infection with HBV-DNA ≥500 IU\u002FmL (2,500 copies\u002FmL) or HBsAg carrier status. Patients with inactive HBsAg carriage or stable active HBV on antiviral therapy with HBV-DNA \\\u003C 500 IU\u002FmL may enrol. HBV-DNA testing is required only for anti-HBc-positive patients.\n11. Active HCV infection. Patients who are anti-HCV-negative, or anti-HCV-positive but HCV-RNA-negative, may enrol. Anti-HCV-positive patients must have HCV-RNA testing.\n12. History of immunodeficiency (including HIV positivity or other acquired\u002Fcongenital immunodeficiencies), or prior allogeneic stem-cell or solid-organ transplantation (Appendix 3).\n13. Known hypersensitivity to other monoclonal antibodies.\n14. Known hypersensitivity to any study drug or excipient.\n15. Unresolved toxicities from prior therapy that have not returned to baseline or stabilised, unless considered by the investigator not to pose a safety risk (e.g. alopecia, neuropathy, certain laboratory abnormalities).\n16. Any condition (medical or substance abuse) that could impede study-drug administration, confound interpretation of results, or place the patient at high risk of complications.",{"count":65,"type":20},12,[67],"PHASE1","When bladder cancer patients are treated to mobilize their own immune system to fight the tumor, drugs that kill the bacteria can impair the effectiveness of the treatment. The purpose of this study is to find out if the common dietary supplement Vitamin B3 could allow drugs that kill bacteria to not negatively affect treatments that mobilize the immune system to fight tumors.",[28],[71,72,73,74],"Antibiotics","Nicotinamide nucleotides","Immunotherapy","Bladder Cancer","2026-06-28",{"date":77,"type":49},"2026-06-30",{"date":79,"type":49},"2025-08-01",{"date":81,"type":20},"2027-02-01",{"name":83,"class":56},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",1,{"id":86,"slug":4,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100629875","NCT07480356","Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer","A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-Grade Non-Muscle Invasive Bladder Cancer","ADVANCED-3","Inclusion Criteria:\n\n* Male or female participants 18 years of age or older at the time of signing informed consent\n* Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry\n* Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta\u002FT1) with active disease\n* Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis, or participants who received ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis\n\nExclusion Criteria:\n\n* Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory\n* Central confirmed variant histology\n* Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment\n* Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)\n* Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history\n\nFor more information on eligibility criteria, please contact the Sponsor.",{"count":93,"type":20},284,[95],"PHASE3","The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older.\n\nThe main questions it aims to answer are:\n\n* Can the study drug help participants with this type of cancer?\n* Is the study drug safe?\n* What are the side effects of the study drug?\n\nResearchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.",[28,98,99],"Non-Muscle Invasive Bladder Carcinoma","Non-muscle Invasive Bladder Cancer With Carcinoma in Situ",[101,102,103,104],"BCG-naive","Non-muscle invasive bladder Cancer","bladder cancer","carcinoma in situ","2026-06-25",{"date":107,"type":49},"2026-06-29",{"date":109,"type":49},"2026-05-29",{"date":111,"type":20},"2032-11",{"name":113,"class":114},"Protara Therapeutics","INDUSTRY",6,{"id":117,"slug":4,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100638648","NCT07625527","Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?","Randomized Trial of Active Surveillance Versus Continued Systemic Immunotherapy After Achieving Tumor-Free Status in Extensive Transurethrally Unresectable Very-High-Risk NMIBC","Inclusion Criteria\n\n* Has histologically confirmed very-high-risk non-muscle-invasive urothelial carcinoma of the bladder.\n* Has transurethrally unresectable bladder tumor, defined as visually incomplete TURBT and\u002For extensive high-volume disease considered unsuitable for complete and oncologically adequate transurethral resection.\n* Has undergone cystoscopy and TURBT evaluation before study enrollment.\n* Has received systemic PD-1\u002FPD-L1 inhibitor-based bladder-sparing therapy before randomization.\n* Has achieved tumor-free status before randomization, defined as:\n\n  1. No visible bladder tumor on cystoscopy;\n  2. Negative bladder biopsy and\u002For TURBT pathology;\n  3. Negative urine cytology;\n  4. Negative urinary tumor DNA (utDNA);\n  5. No radiographic evidence of progression or metastasis.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n* Has adequate organ function.\n* Has provided written informed consent.\n\nCohort A Only\n\n* Achieved tumor-free status at the initial response evaluation after induction systemic therapy.\n* Maintained tumor-free status after additional systemic therapy before randomization.\n\nCohort B Only\n\n* Did not achieve tumor-free status at the initial response evaluation because of residual non-muscle-invasive disease.\n* Subsequently underwent complete TURBT\u002Fresection of residual disease followed by additional systemic therapy.\n* Achieved tumor-free status at the second response evaluation before randomization.\n\nExclusion Criteria\n\n* Has muscle-invasive bladder cancer (≥T2), locally advanced unresectable disease, nodal disease, or distant metastasis.\n* Has concurrent upper tract urothelial carcinoma.\n* Has persistent visible tumor, positive bladder pathology, positive urine cytology, or positive utDNA before randomization.\n* Has received prior systemic immunotherapy for metastatic urothelial carcinoma.\n* Has active autoimmune disease requiring systemic treatment.\n* Is receiving systemic immunosuppressive therapy.\n* Has uncontrolled infection requiring systemic therapy.\n* Has another active malignancy requiring systemic treatment.\n* Has known active hepatitis B, hepatitis C, human immunodeficiency virus infection, or active tuberculosis.\n* Has pregnancy or breastfeeding.\n* Has any medical or psychiatric condition that, in the investigator's judgment, would interfere with study participation or interpretation of results.",{"count":123,"type":20},120,[125],"PHASE2","Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC) may achieve a tumor-free status after systemic immunotherapy-based bladder-sparing treatment combined with transurethral resection of bladder tumor (TURBT). However, the optimal duration of systemic immunotherapy after achieving a tumor-free status remains uncertain. Prolonged treatment may increase toxicity, treatment burden, and cost, while some patients may maintain durable disease control without continued therapy.\n\nThis randomized study aims to evaluate whether active surveillance after achieving tumor-free status is a feasible alternative to continued systemic immunotherapy in patients with extensive transurethrally unresectable very-high-risk NMIBC.\n\nPatients will initially receive systemic immunotherapy-based treatment followed by disease evaluation using cystoscopy with biopsy and\u002For TURBT, urine cytology, urinary tumor DNA (utDNA), and imaging assessments. Patients who achieve tumor-free status after treatment and complete resection of visible disease will be randomized to either active surveillance or continued systemic immunotherapy.\n\nThe study will evaluate recurrence outcomes, bladder preservation, progression, safety, and patient management strategies following achievement of tumor-free status. The trial also aims to explore the role of urinary tumor DNA in identifying patients who may safely undergo treatment de-escalation and active surveillance.",[28,128],"Non Muscle Invasive Bladder Cancer",[130,131,73],"Non-muscle-invasive bladder cancer (NMIBC)","Liquid biopsy","NOT_YET_RECRUITING","2026-05-28",{"date":135,"type":49},"2026-06-04",{"date":137,"type":20},"2026-05-30",{"date":139,"type":20},"2032-05-30",{"name":141,"class":56},"Tianjin Medical University Second Hospital",4,{"id":144,"slug":4,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":150,"minAge":17,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":21,"phases":153,"briefSummary":154,"conditions":155,"keywords":156,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100599118","NCT07080333","MICROBIOTA AND BLADDER CANCER","BLADDER MICROBIOTA AND BLADDER CANCER","MICROBLADDERK","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Male\n* First RTUV for suspected CV in the presence of macroscopic haematuria or other clinical signs and\u002For urinary cytology and\u002For cystoscopy and\u002For imaging tests suggestive of CV\n* Signed informed consent form\n* Affiliation with a social security scheme\n\nExclusion Criteria:\n\n* Antibiotic use within 3 months prior to inclusion\n* Current urinary tract infection (urine culture recommended by the AFU prior to RTUV)\n* History of surgical treatment of the urinary and genital tracts within the last 6 months prior to inclusion\n* History of RTUV\n* History of pelvic radiotherapy\n* Interstitial cystitis\n* Patients with an indwelling urinary catheter\n* Vulnerable patients: minors, patients under guardianship or curatorship\n* Patients with benign tumours after receipt of the pathological report (inverted papilloma, non-tumour inflammatory lesion)","MALE",{"count":152,"type":20},95,[23],"In France, bladder cancer (BC) is the fourth leading cause of cancer (14,000 new cases per year). It affects older men (\\>60 years old) and smoking is the main identified risk factor (RF). The persistence of a high sex ratio despite the increase in smoking among women has led to research into other environmental RFs for BC, which may include the microbiota.\n\nRecently, the concept of urinary microbiota in asymptomatic patients has been accepted. Studies on the urinary microbiota have shown dysbiosis associated with certain urogenital pathologies. Thus, similar to certain dysbiosis of the colonic mucosa microbiota associated with CRC, it is possible that certain bacteria or viruses in the bladder tissue microbiota may be involved in bladder carcinogenesis. An epidemiological study conducted by our laboratory showed a prevalence of BC of 14% (7\u002F50) in patients carrying the bacterium Actinotignum schaalii in their urine. While studies have analysed the urinary microbiota of patients with BC, those comparing the microbiota of cancerous bladder tissue with that of healthy tissue in patients with BC remain few in number, involve a limited number of patients, use uncontrolled sample collection, and have all used 16S rDNA-targeted metagenomics methods to study the composition of the microbiota. The authors show a difference in biodiversity between the microbiota of cancerous bladder tissue and that of healthy tissue.\n\nThe team hopes to confirm these preliminary results with a multicentre study using a more comprehensive genomic method, global metagenomics. The microbiota of cancerous bladder tissue will be compared with that of healthy bladder tissue in the same patient to highlight any bacterial or viral dysbiosis associated with the cancerous area.",[28],[157,158,159],"Bladder","cancer","microbiota","2026-05-22",{"date":162,"type":49},"2026-05-26",{"date":164,"type":49},"2026-03-23",{"date":166,"type":20},"2028-10-30",{"name":168,"class":56},"Centre Hospitalier Universitaire de Nice",8,{"id":171,"slug":4,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":179,"conditions":180,"keywords":185,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":84},"100637539","NCT07589413","Association Between Irrigation Fluid Absorption and Perioperative cfDNA Dynamics After TURBT","A Predictive Model for Recurrence and Progression Risk After TURBT for Bladder Cancer on Intraoperative Irrigation Fluid Absorption Volume and Perioperative cfDNA Levels","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Suspected or histologically confirmed urothelial carcinoma of the bladder.\n3. Scheduled to undergo TURBT.\n4. Availability of sufficient peripheral blood samples for cfDNA extraction and mutation analysis.\n5. Availability of complete clinicopathological and perioperative data.\n6. Ability to provide informed consent and comply with study follow-up.\n\nExclusion Criteria:\n\n1. Non-urothelial bladder malignancy confirmed by pathology.\n2. History of other malignant tumors within the past 5 years, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.\n3. Previous radical cystectomy or systemic antitumor therapy before enrollment.\n4. Inadequate blood sample quality or insufficient DNA yield for mutation analysis.\n5. Pregnancy or breastfeeding.\n6. Serious uncontrolled intercurrent illness that may interfere with study participation, follow-up, or compliance, including active infection, symptomatic congestive heart failure, unstable angina, clinically significant arrhythmia, severe psychiatric illness, or other conditions judged by the investigator to make participation unsuitable.",{"count":177,"type":20},150,"OBSERVATIONAL","This prospective observational cohort study aims to evaluate the association between intraoperative irrigation fluid absorption and perioperative cell-free DNA (cfDNA) dynamics in patients undergoing transurethral resection of bladder tumor (TURBT). Eligible patients with suspected or confirmed bladder cancer scheduled for TURBT will be enrolled. Intraoperative irrigation fluid absorption volume will be recorded, and peripheral blood samples will be collected before surgery and within 24 hours after surgery for cfDNA extraction and mutation analysis.\n\nThe study will assess whether irrigation fluid absorption volume is associated with changes in cfDNA concentration, tumor-related mutation detection, and clinicopathological features, including tumor stage, grade, size, number, invasion depth, concomitant carcinoma in situ, operative time, resection depth, and intraoperative blood loss. Patients will also be followed for postoperative recurrence, progression, metastasis, and other adverse oncological outcomes.\n\nThis study may provide preliminary evidence for understanding perioperative tumor-related molecular changes during TURBT and may help improve risk stratification, perioperative management, and postoperative follow-up strategies for patients with bladder cancer.",[28,181,182,183,184],"Bladder Cancer Recurrence","Progression of Bladder Cancer","Transurethral Resection of Bladder Tumor","Urothelial Carcinoma of the Bladder",[103,186,187,188,189,190,191,192,193,194],"nucleic acid mass spectrometry","TURBT","urothelial carcinoma","cell-free DNA","irrigation fluid absorption","circulating tumor DNA","mutation profiling","recurrence","progression","2026-05-09",{"date":197,"type":49},"2026-05-15",{"date":199,"type":49},"2026-04-01",{"date":201,"type":20},"2027-04-01",{"name":203,"class":56},"Zhiping Wang",{"id":205,"slug":4,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":84},"100576573","NCT06787053","Selecting Hypoxic Tumours for Treatment Modification","SELECT","Inclusion Criteria:\n\nThis will be tumour site dependent.\n\nBladder:\n\n* Older than age 18 years.\n* Patients having radiotherapy at the Christie NHS Foundation Trust suitable for imaging on an MRI scanner.\n* Able to give informed consent.\n\nCervix:\n\n* Older than age 18 years.\n* Patients having radiotherapy at the Christie NHS Foundation Trust suitable for imaging on an MRI scanner.\n* Able to give informed consent.\n\nProstate:\n\n* Older than age 18 years.\n* Patients having radiotherapy at the Christie NHS Foundation Trust suitable for imaging on an MRI scanner.\n* Able to give informed consent.\n\nExclusion Criteria:\n\nThis will be tumour site dependent\n\nBladder:\n\n* Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.\n* Unable to tolerate MRI scans.\n* Pregnancy.\n\nCervix:\n\n* Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.\n* Unable to tolerate MRI scans.\n* Pregnancy.\n\nProstate:\n\n* Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.\n* Unable to tolerate MRI scans",{"count":211,"type":20},30,"Approximately 50% of cancer patients with solid tumours will be treated with radiotherapy. A significant proportion (\\>25%) of patients have hypoxic tumours which respond poorly to radiotherapy. Hypoxic tumours have a poor prognosis. This can be improved with treatment intensification. Treatment intensification can be modification with CON (breathing O2-enriched air + oral administration of nicotinamide), chemoradiosensitisation, radiation dose-escalation or additional systemic treatments, significantly improving response of the tumours to radiotherapy. However, there are currently no clinically approved biomarkers to identify hypoxic tumours. Our group has developed and validated gene-expression signature-based biomarkers that identify patients with hypoxic bladder, head and neck , prostate, sarcoma and lung cancers. The bladder cancer gene-expression hypoxia signature has been shown to predict benefit from hypoxia modification using RNA from archived tumour tissue. The main purpose of this study is to demonstrate in at least two cancer types that the hypoxia biomarker predicts benefit from hypoxia modification in real-time.",[28,42],[215,157,216,217,218],"Hypoxia","Cervix","Prostate","Hypoxia Modification",{"date":220,"type":49},"2026-05-12",{"date":222,"type":49},"2024-10-16",{"date":224,"type":20},"2028-05-30",{"name":226,"class":56},"University of Manchester",{"id":228,"slug":4,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":21,"phases":236,"briefSummary":237,"conditions":238,"keywords":243,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":4},"100628630","NCT07464145","A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer","A Phase 3 Study Evaluating the Efficacy and Safety of NDV-01 in Participants With Non-muscle Invasive Bladder Cancer (RESCUE)","RESCUE","Cohort 1 Inclusion Criteria:\n\n1. Be ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place) at the time of informed consent.\n2. Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA\u002FSUO criteria of IR NMIBC (excluding LGT1 tumors).\n3. Participant must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence\u002Fprogression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.\n4. Participant must have ≥ 1 IBCG risk factors: 1) multiple tumors, 2) early recurrence (within 1 year), 3) frequent recurrences (\\> 1 per year), 4) tumor size (\\> 3 cm), 5) failure of prior induction intravesical therapy.\n5. Visible papillary disease must be fully resected prior to randomization, and absence of disease must be documented at Screening cystoscopy. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced cystoscopic method \\[e.g., blue light cystoscopy, narrow-band imaging\\]).\n\n   All pathology specimens must be predominantly urothelial (transitional cell) and have less than 20% variant (e.g., sarcomatoid, squamous component) histology.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n\nCohort 1 Exclusion Criteria:\n\n1. Histologically confirmed stage T1 tumors.\n2. Histologically confirmed diagnosis of HR NMIBC (including CIS) or muscle-invasive bladder cancer (MIBC), locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.\n3. Has had urothelial carcinoma outside of the urinary bladder (including prostatic urethra, ureter, or renal pelvis) or has a predominant histological variant of urothelial carcinoma (UC). Ta\u002Fany T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study.\n4. Participant has tumor(s) involving the prostatic urethra (ductal or stromal).\n5. N+ and\u002For M+ per computed tomography (CT)\u002Fmagnetic resonance (MR) urography.\n6. Received an investigational treatment for bladder cancer within 6 months prior to randomization, before the planned first dose of study treatment, or is currently enrolled in an investigational study.\n7. Received adjuvant induction intravesical chemotherapy within 3 months of current diagnosis. Peri-operative instillation of a single dose of intravesical chemotherapy is allowed per institutional guidelines.\n8. Received prior intravesical treatment with immunotherapy, including BCG, within 3 months prior to randomization.\n\nCohort 2 Inclusion Criteria:\n\n1. Cohort 2a: BCG-unresponsive NMIBC with CIS of the bladder, with or without coexisting papillary Ta\u002FT1 tumor(s) who are ineligible for or have elected not to undergo cystectomy at the time of enrollment and have received 1 or 2 lines of therapy after meeting criteria for BCG unresponsiveness and experienced biopsy confirmed CIS disease within 12 months of last treatment, where:\n\n   * Adequate BCG regimen consists of at least 2 courses of BCG, where the first course (induction) must have included at least 5 of 6 doses and the second course may have included a re-induction (at least 2 of 6 treatments) or maintenance (at least 2 of 3 doses). Adequacy of the BCG regimen will be determined by the Investigator in conjunction with the Sponsor.\n   * Treatment after BCG unresponsiveness includes either approved or in development therapy\n   * Post-treatment presence of CIS must be documented or indicated by pathology at screening or within 4 months of screening (provided no therapy for CIS disease was given after the most recent biopsy).\n   * For inclusion, a participant with BCG-unresponsive disease (as defined above) must have received up to two lines of therapy for BCG-unresponsive disease and who are being considered for radical cystectomy. Such therapies may include agents approved or in development (e.g., pembrolizumab, nadofaragene firodenovec, nogapendekin alfa inbakicept-pmln, cretostimogene grenadenorepvec, detalimogene voraplasmid, TARA-002, gemcitabine intravesical system (INLEXZO®), gemcitabine-docetaxel, gemcitabine, MMC, or valrubicin monotherapy. Participant will have demonstrated biopsy-proven recurrence with HG papillary disease (without CIS) after one or two first-line therapy(ies).\n2. Cohort 2b: BCG-unresponsive NMIBC of the bladder, with papillary Ta\u002FT1 tumor(s) and without co-existing CIS, who are ineligible for or have elected not to undergo cystectomy at the time of enrollment and have experienced recurrent Ta\u002FT1 disease within 12 months of treatment with 1 or 2 lines of therapy after BCG-unresponsive status.\n\n   * For inclusion, a participant with BCG-unresponsive disease (as defined above) must have received up to two lines of therapy for BCG-unresponsive disease and who are being considered for radical cystectomy. Such therapies may include agents approved or in development (e.g., pembrolizumab, nadofaragene firodenovec, nogapendekin alfa inbakicept-pmln, cretostimogene grenadenorepvec, detalimogene voraplasmid, TARA-002, gemcitabine intravesical system (INLEXZO®), gemcitabine-docetaxel, gemcitabine, MMC, or valrubicin monotherapy. Participant will have demonstrated biopsy-proven recurrence with HG papillary disease (without CIS) after one or two first-line therapy(ies).\n\nAll Cohort 2\n\n1. A participant with HG T1 may be eligible after repeat-TURBT showing non-invasive (Ta or less) or no disease. Either original or repeat-TURBT must confirm that muscularis propria is present and uninvolved in the specimen.\n2. All specimens must be predominantly urothelial (transitional cell) carcinoma with or without squamous or glandular differentiation. Pure squamous or glandular tumors will not be included. A participant with less than 10% micropapillary histology will be included. All other variant histology (e.g., plasmacytoid, small cell, nested, trophoblastic variants) will not be included.\n\nCohort 2 Exclusion Criteria:\n\n1. Has had urothelial carcinoma outside of the urinary bladder (i.e., urethra, ureter, or renal pelvis) or has a predominant histological variant of UC. Ta\u002Fany T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study and is considered to be without evidence of recurrent disease.\n\n   * Participants have tumor(s) involving the prostatic urethra (ductal or stromal).\n   * N+ and\u002For M+ per computerized tomography (CT)\u002FMagnetic Resonance Imagery (MR) urography.\n2. History of prior T2\u002FT3 urothelial carcinoma of the bladder.\n3. Concurrent treatment with any chemotherapeutic agent.\n4. Intravesical chemotherapy within 3 months of enrollment (including INLEXZO®, gemcitabine-docetaxel)",{"count":235,"type":20},393,[95],"Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC. The study will include two cohorts:\n\n* Cohort 1: a randomized, open-label, parallel group, multi-center, Phase 3 study evaluating the efficacy and safety of the NDV-01 versus observation in participants with histologically confirmed IR-NMIBC.\n* Cohort 2: an open-label, multi-center, single-arm Phase 3 study evaluating the efficacy and safety of the NDV-01 in two populations of high-risk NMIBC:\n\n  * Cohort 2a: will include participants with HR-NMIBC who have a biopsy-proven recurrence with CIS ± papillary disease after receiving one or 2 lines of therapy for BCG-unresponsive NMIBC (approved or in development).\n  * Cohort 2b: will include participants with high-risk papillary-only disease (without CIS) NMIBC who have a biopsy-proven recurrence with HG papillary disease after receiving one or 2 lines of therapy for BCG-unresponsive NMIBC (approved or in development).\n\nThis study will evaluate the safety and efficacy of intravesical administration of NDV-01, and its effect on disease recurrence and progression in patients with NMIBC who have IR disease and have recently undergone a TURBT (Cohort 1) and in patients who have HR BCG-unresponsive disease and who have recurred after first-line therapy for BCG-unresponsive patients - both approved and in development - and are unwilling or unable to undergo radical cystectomy (Cohort 2). Both GEM and DOCE have established safety and efficacy across a range of tumor types, including IR and BCG-unresponsive NMIBC. By combining both GEM and DOCE in an intravesical extended-release formulation, Relmada believes that NDV-01 has the potential to be an agent for second-line therapy in patients who have recurred after first-line therapy in BCG-unresponsive disease, thereby avoiding radical cystectomy. This study will serve as a master protocol for all cohorts included in the study.",[28,239,240,241,242],"Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)","Urothelial Carcinoma Bladder","Urothelial Carcinoma Recurrent","Urologic Cancer",[244,245,103],"NMIBC","non-muscle-invasive bladder cancer","2026-03-05",{"date":248,"type":49},"2026-03-11",{"date":250,"type":20},"2026-06",{"date":252,"type":20},"2032-09",{"name":254,"class":114},"Relmada Therapeutics, Inc.",{"id":256,"slug":4,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":84},"100626889","NCT07441499","Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma","Inclusion Criteria:\n\n* Suspected or histologically confirmed urothelial carcinoma\n\nExclusion Criteria:\n\n* History of or concurrent active malignancy other than urothelial carcinoma",{"count":261,"type":20},300,"Application of Multi-Component Liquid Biopsy (ctDNA, utDNA, Exosomes, and Protein Biomarkers in Blood and Urine) for Auxiliary Diagnosis, Therapeutic Response Evaluation, and Recurrence Monitoring in Urothelial Carcinoma",[264,28,265],"Urothelial Carcinoma (UC)","Liquid Biopsy","2026-02-27",{"date":268,"type":49},"2026-03-02",{"date":270,"type":20},"2026-03",{"date":272,"type":20},"2029-01-01",{"name":141,"class":56},{"id":275,"slug":4,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":281,"targetDuration":283,"studyType":178,"phases":4,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":4},"100623392","NCT07396038","INTRAOPERATIVE BLADDER INJURY ASSESSMENT IN TURBT USING BICEP","Evaluation of Intraoperative Bladder Injuries During Transurethral Resection of Bladder Tumors Using the BICEP Classification (BICEP on TURBT)","BICEP in TURBT","Inclusion Criteria:\n\n* Adult patients aged 18 years or older\n* Patients undergoing transurethral resection of bladder tumor\n* Procedures performed for primary resection, re-resection, diagnostic, or staging purposes\n\nExclusion Criteria:\n\n* Patients with incomplete intraoperative data regarding bladder injury assessment\n* Patients who decline participation, if informed consent is required",{"count":282,"type":20},1000,"12 Months","Transurethral resection of bladder tumor (TURBT) is the cornerstone procedure in the diagnosis and treatment of bladder cancer but is associated with a spectrum of intraoperative bladder injuries ranging from minor mucosal tears to major perforations. Currently, there is no standardized intraoperative classification system specifically designed to grade and report these injuries during TURBT.\n\nThis study aims to apply the Bladder Injury Classification System for Endoscopic Procedures (BICEP) to TURBT in order to systematically classify intraoperative bladder injuries, evaluate their management, and explore their association with perioperative and early postoperative outcomes.",[28,187,286],"Bladder Injury",[288,289,290,291,292,293],"Transurethral resection of bladder tumor","Bladder perforation","Bladder cancer surgery","Bladder injury classification","Ureteral orifice injury","Endoscopic bladder surgery complications","2026-02-05",{"date":296,"type":49},"2026-02-09",{"date":298,"type":20},"2026-02-15",{"date":300,"type":20},"2027-03-30",{"name":302,"class":56},"Necmettin Erbakan University",{"id":304,"slug":4,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":310,"targetDuration":311,"studyType":178,"phases":4,"briefSummary":312,"conditions":313,"keywords":316,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":84},"100621824","NCT07375641","The Impact of Age and Sex on Anticipated and Experienced Pain in First-Time Outpatient Flexible Cystoscopy","The Effect of Age and Sex on Pre-procedural Anticipated Pain and Post-procedural Experienced Pain in Patients Undergoing Flexible Cystoscopy for the First Time in an Outpatient Setting","PAINCYST","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients undergoing flexible cystoscopy for the first time under local anesthesia in an outpatient setting\n* Ability to understand the study procedures and provide informed consent\n\nExclusion Criteria:\n\n* Use of systemic analgesics, sedatives, or anxiolytics immediately before the procedure\n* Presence of active urinary tract infection at the time of cystoscopy\n* Presence of an indwelling urethral catheter at the time of cystoscopy",{"count":177,"type":20},"1 Day","Cystoscopy is a procedure frequently performed in daily urological practice for the diagnosis of various urological conditions, including bladder tumors, benign prostatic hyperplasia, recurrent cystitis, and urethral strictures. Cystoscopy can be performed either in the operating room under sedation, spinal anesthesia, or general anesthesia, or in the outpatient setting under local anesthesia. Performing cystoscopy under outpatient conditions for patients requiring the procedure for follow-up and treatment indications is important in terms of reducing the workload of operating rooms. Although cystoscopy is generally well tolerated under local anesthesia in the outpatient setting, it may cause pain and anxiety in some patients, even when a flexible cystoscope is used. This may lead to adverse outcomes, particularly in patients with bladder tumors, due to loss to follow-up. Despite the use of analgesic methods such as lidocaine-based lubricants to reduce pain and anxiety before cystoscopy, an optimal solution has not yet been achieved. Moreover, some studies have reported that the level of pain experienced during cystoscopy increases with advancing age.\n\nIn male patients, several studies have demonstrated that the most painful moment during cystoscopy occurs when the tip of the cystoscope passes through the external urinary sphincter. It has been shown that asking patients to take deep breaths or allowing them to watch cystoscopy videos while manually compressing the irrigation fluid bag during the passage of the cystoscope through the bulbar urethra, just distal to the external urinary sphincter, can reduce pain perception. Female patients tend to experience less pain due to the shorter urethral length. Various strategies have been employed to minimize pain and anxiety during the procedure, including listening to music, watching relaxing videos, or allowing patients to view their own cystoscopy recordings during the examination. Given the lack of prior cystoscopy experience, we planned this randomized prospective study to evaluate the effect of age and sex on pain perception during flexible cystoscopy. We believe that the findings of this study may be beneficial in counseling patients during cystoscopic evaluation of urological pathologies",[314,28,315],"Urethral Stricture","Benign Prostate Obstruction (BPO)",[317,318,319],"flexible cystoscopy","outpatient urology","pain perception","2026-01-22",{"date":322,"type":49},"2026-01-29",{"date":324,"type":20},"2026-02-01",{"date":326,"type":20},"2026-05-01",{"name":328,"class":329},"Kayseri Education and Research Hospital","OTHER_GOV",{"id":331,"slug":4,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":21,"phases":338,"briefSummary":339,"conditions":340,"keywords":341,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":349,"leadSponsor":351,"locationsCount":4},"100620374","NCT07356791","Phase II Prospective Cohort Study of Intravesical Recombinant Human Type 5 Adenovirus Injection for Treatment of High-Risk Non-Muscle Invasive Bladder Cancer: Evaluating Efficacy and Safety","Phase II Prospective Cohort Study of Intravesical Recombinant Human Type 5 Adenovirus Injection for Treatment of High-Risk Non-Muscle Invasive Bladder Cancer: Evaluating Efficacy and Safety (REBIRTH-013)","REBIRTH-013","Inclusion Criteria:\n\n* Voluntarily participate in this clinical study, understand the study procedures, and provide written informed consent.\n* Aged ≥18 years, regardless of gender.\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.\n* Expected survival time ≥2 years.\n* Histologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC) (\"high-risk\" defined in Appendix 1 ).\n* No residual lesions after cystoscopy or transurethral resection of bladder tumor (TURBT) within 6 weeks prior to the first dose, or residual lesions limited to carcinoma in situ (CIS).\n* Adequate Hematologic and Organ Function :\n\nHematologic (no blood transfusion, growth factors, or hematopoietic stimulants within 14 days):\n\nAbsolute neutrophil count (ANC) ≥1.0×10⁹\u002FL; Platelet count (PLT) ≥100×10⁹\u002FL; Hemoglobin (Hb) ≥80 g\u002FL.\n\nLiver Function :\n\nTotal bilirubin (TBIL) ≤2×ULN; Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤3×ULN.\n\nRenal Function :\n\nSerum creatinine (Cr) ≤1.5×ULN.\n\nElectrocardiogram (ECG) :\n\nQTc interval ≤450 ms (male) or ≤470 ms (female), corrected by Fridericia's formula (QTc = QT\u002F(RR⁰·³³)).\n\nCardiac Ultrasound :\n\nLeft ventricular ejection fraction (LVEF) ≥50%.\n\nCoagulation :\n\nActivated partial thromboplastin time (APTT) ≤1.5×ULN; International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN. Contraception Requirements\n\n* Non-sterilized participants of childbearing potential (male or female) must agree to use effective contraception (e.g., intrauterine device, oral contraceptives) during the study and for 3 months after treatment.\n\nFemale participants (or female partners of male participants) must use highly effective contraception.\n\n* Non-sterilized female participants must have a negative serum HCG test within 7 days before the first dose and must not be lactating.\n\nExclusion Criteria:\n\n* Prior Bladder Radiotherapy\n* Prior Treatments Without Disease Progression (as Assessed by Investigator)\n* Previous intravesical therapy with cytotoxic chemotherapy or other agents (e.g., oncolytic viruses, IL-2).\n* Systemic chemotherapy, immune checkpoint inhibitors, or antibody-drug conjugates (ADCs).\n* Participation in other investigational drug trials for NMIBC.\n* Intravesical Bacillus Calmette-Guérin (BCG) treatment within 2 weeks before the first dose (eligible if washout period exceeds 2 weeks).\n* Currently receiving investigational treatment in another clinical trial or completion of such treatment \\\u003C4 weeks before the first dose in this study.\n* Upper urinary tract or urethral tumors detected during screening ( CTU\u002FMRU ). Other malignancies within 5 years before the first dose (exceptions: completely resolved carcinoma in situ or indolent malignancies like prostate cancer, per investigator's judgment).\n* Active severe infections requiring IV antibiotics, antivirals, or antifungals. Grade ≥3 urinary tract infection (UTI) not recovered to Grade ≤2.\n* Previous BCG therapy discontinued due to adverse events (e.g., sepsis, systemic infection, urinary incontinence) unless fully recovered to Grade ≤2 .\n* Clinically Significant Cardiovascular Disease , including but not limited to:\n\nCongestive heart failure ( NYHA Class \\>2 ); Unstable angina; Severe myocardial infarction within 6 months ; Symptomatic arrhythmias requiring intervention.\n\n* Immunodeficiency or Transplant History , including HIV-positive serology and other acquired\u002Fcongenital immunodeficiencies.\n* History of organ transplantation or current immunosuppressant use.\n* Active Viral Hepatitis Hepatitis B : HBeAg-positive and HBV DNA ≥500 IU\u002FmL. Hepatitis C : Anti-HCV-positive and HCV RNA above the lower limit of detection.\n\nHypersensitivity or Intolerance\n\n* Known allergy or intolerance to the study drug or its excipients.\n* Any other severe physical\u002Fpsychiatric illness, abnormal lab results, or factors that may: Increase study participation risks; Interfere with study results; Investigator's discretion for ineligibility.",{"count":57,"type":20},[125],"This is a prospective, open label, single center clinical study on the use of recombinant human adenovirus type 5 injection for bladder instillation therapy in high-risk non muscle invasive bladder urothelial carcinoma patients. The study was administered in a dose escalation manner, starting from a relatively safe dose of 1.0 × 10 \\^ 12vp as the first dose group, and a 6-week DLT observation period was set up to ensure the safety of the study. Expected to enroll 12-18 participants. The subjects need to undergo maximum transurethral resection of the bladder (TURBT) and imaging diagnosis, and biological samples such as blood, urine, and biopsy tissue should be collected before treatment. The patient will receive bladder instillation therapy with recombinant human adenovirus type 5 injection after TURBT surgery. The subjects should receive a fixed dose of recombinant human adenovirus type 5 injection (1.0 × 10 \\^ 12 vp or 2.0 × 10 \\^ 12 vp or 3.0 × 10 \\^ 12 vp) per week via bladder instillation for 6 weeks for induction therapy, followed by maintenance infusion of the same dose once a week for 3 weeks after the first induction infusion at 3, 6, 12, 18, and 24 months. After the first intravesical intervention for 3 months, tumor site pathology, imaging, and cytology will be obtained through diagnostic TURBT for tumor evaluation. Patients who achieve complete remission will maintain the same induction cycle, and will receive follow-up every 3 months for 2 years, every 6 months for more than 2 years, and once a year for more than 3 years. Patients who are intolerant to intravesical treatment (evaluated by the researchers) will be directly discontinued.",[28],[342,343,344],"High-risk non-muscle invasive bladder cancer (HR-NMIBC)","Bladder carcinoma in situ (CIS)","Intravesical adenovirus therapy","2026-01-12",{"date":347,"type":49},"2026-01-21",{"date":324,"type":20},{"date":350,"type":20},"2027-12-31",{"name":352,"class":56},"RenJi Hospital",{"id":354,"slug":4,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":360,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":21,"phases":363,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":383},"100598608","NCT07073703","Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer.","Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer - FRAGECO - Multicenter, Controlled, Randomized Study","FRAGECO","Inclusion Criteria:\n\n* Diagnosis of bladder or kidney cancer\n* Surgical treatment\n* No severe cognitive impairment preventing understanding of the protocol\n* Affiliated or entitled to a social security scheme\n* Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study\n\nExclusion Criteria:\n\n* Surgery already done\n* Significant co-morbidities that contraindicate physical activity: associated cardiac pathologies, respiratory pathologies, disabling joint pathologies, etc.\n* Deprived of liberty or under guardianship\n* Benefiting from a prehabilitation prescription with a private physiotherapist.","65 Years",{"count":362,"type":20},106,[23],"Bladder and kidney cancers are commonly diagnosed in older adults. Surgery remains the primary treatment modality for patients with kidney or bladder cancer. In older patients, common co-morbidities include fatigue, physical deconditioning characterized by reduced cardiorespiratory fitness and progressing sarcopenia, pain- whether disease- related or treatment-induced- and undernutrition. These factors increased the risk of post-operative complications and exacerbate patient frailty.\n\nThe investigators propose a personalized 6-month program both pre- and post-surgery, including adapted physical activity sessions, therapeutic education workshops, and systematic referral to the department's DAPAP program.",[28,366],"Kidney (Renal Cell) Cancer",[368,369,370,157,371,372,373],"Exercise","Older people","Cancer","Kidney","Frailty","Surgery","2025-12-08",{"date":376,"type":49},"2025-12-09",{"date":378,"type":49},"2025-12-03",{"date":380,"type":20},"2028-03",{"name":382,"class":56},"Centre Hospitalier Universitaire de Saint Etienne",2,{"id":385,"slug":4,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":21,"phases":393,"briefSummary":395,"conditions":396,"keywords":397,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":406,"locationsCount":4},"100613900","NCT07272603","Bladder Perfusion of Plasma-Activated Saline for Bladder Cancer","Preliminary Clinical Study Evaluating the Therapeutic Response and Safety of Intravesical Perfusion With Plasma-Activated Saline Solution in Patients With Bladder Cancer","Inclusion Criteria:\n\n1. Patients with a pathological diagnosis of bladder cancer.\n2. Patients scheduled for radical cystectomy, with at least one measurable tumor lesion ≥10 mm in diameter.\n3. Age between 18 and 75 years.\n4. Treatment-naïve patients who have not received any prior therapy for bladder cancer.\n\nExclusion Criteria:\n\n1. Presence of severe comorbidities, including but not limited to cardiac disease, severe hepatic or renal insufficiency, uncontrolled hypertension, or diabetes.\n2. Active urinary tract infection or a functional bladder capacity of less than 200 mL.\n3. History of other malignancies.\n4. Pregnancy or lactation.\n5. Poor compliance, assessed as unlikely to complete the trial per protocol requirements.\n6. Any other condition deemed by the investigator to make the patient unsuitable for study participation.","75 Years",{"count":392,"type":20},5,[394],"EARLY_PHASE1","This preliminary clinical study evaluates the safety and initial efficacy of a novel therapy called Plasma-Activated Saline Solution (PASS) for bladder cancer patients. The study involves a one-week course of PASS administered via bladder infusion in five pre-surgical patients, using imaging and pathology analyses to assess tumor shrinkage and cancer cell death, while closely monitoring for any adverse reactions to explore the therapy's future potential.",[28],[398,158,399,400],"bladder","Intravesical Perfusion","plasma","2025-11-26",{"date":376,"type":49},{"date":404,"type":20},"2025-12-15",{"date":298,"type":20},{"name":407,"class":56},"Qilu Hospital of Shandong University",{"id":409,"slug":4,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":21,"phases":417,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":84},"100608920","NCT07207824","DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC","A Phase III Randomized Controlled Trial of Disitamab Vedotin (DV) Combined With Bacillus Calmette-Guérin (BCG) in BCG-Naïve Patients With HER2-Expressing, High-Risk Non-Muscle-Invasive Bladder Cancer","HERO","Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Histologically confirmed high-risk, non-muscle-invasive urothelial carcinoma of the bladder (UCC) (with \\>50% urothelial carcinoma as the predominant histological component), defined by the presence of any of the following: a. T1 tumor; b. High-grade Ta tumor; c. Carcinoma in situ (CIS).\n3. Complete resection of all Ta\u002FT1 papillary lesions (including patients with concomitant CIS). The most recent Transurethral Resection of Bladder Tumor (TURBT) must have been performed within 12 weeks prior to randomization. A second TURBT was required if indicated per current local applicable guidelines.\n4. HER2 expression (IHC 1+\u002F2+\u002F3+) as confirmed by immunohistochemistry (IHC) testing at the local institution's pathology department.\n5. Unwillingness or ineligibility to undergo radical cystectomy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.\n7. Signed informed consent form (ICF).\n\nExclusion Criteria\n\n1. Histologically confirmed evidence of muscle-invasive (T2 or higher), locally advanced, or metastatic urothelial carcinoma, or the presence of concurrent extravesical non-muscle-invasive urothelial carcinoma.\n2. Histopathological findings of pure small cell carcinoma, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.\n3. History of upper tract urothelial carcinoma (except for cases with no recurrence within 2 years following radical treatment for UTUC).\n4. Prior therapy with any other type of HER2-targeted inhibitor.\n5. Major surgery within 2 weeks prior to randomization.\n6. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.",{"count":416,"type":20},182,[95],"The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk. Each participant was assigned to one of two study treatment groups: One group is given Disitamab Vedotin and BCG.The second group is given BCG only and will not receive Disitamab Vedotin.",[28,244],[244,421,422,423],"disitamab vedotin","HER2","BCG","2025-09-28",{"date":426,"type":49},"2025-10-06",{"date":428,"type":20},"2025-12-01",{"date":430,"type":20},"2030-12-01",{"name":432,"class":56},"Fudan University",{"id":434,"slug":4,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":21,"phases":442,"briefSummary":443,"conditions":444,"keywords":446,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":383},"100608625","NCT07203989","The Effect of Video Calls With Family Members During Operating Room Waiting on Stress, Anxiety, and Surgical Fear in Patients Undergoing Transurethral Resection of Bladder Tumor","The Effect of Video Calls With Family Members During Operating Room Waiting on Stress, Anxiety, and Surgical Fear in Patients Undergoing Transurethral Resection of Bladder Tumor: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* Able to read and write in Turkish\n* Scheduled for transurethral resection of bladder tumor (TURBT)\n* Has a family member, friend, or relative able to participate in video calls\n* The accompanying family member or relative has a device suitable for video calls (smartphone, tablet, etc.)\n* Has waited at least 20 minutes in the operating room before surgery\n* No hearing, speech, or language-related communication barriers\n* No psychological disorders that could affect fear or anxiety\n* Not using medications that could alter fear or anxiety levels\n* Scheduled for surgery between 08:00 and 12:00\n* Willing to voluntarily participate in the study\n\nExclusion Criteria:\n\n* Surgery is canceled after the patient has been enrolled in the study\n* Patient chooses to withdraw from the study after enrollment\n* Individuals with any diagnosed chronic disease\n* Experiencing connection problems during the video call\n* Patients who receive premedication during the waiting period to relieve anxiety","100 Years",{"count":441,"type":20},124,[23],"This study aims to investigate the effect of video calls with family members during the preoperative waiting period in the operating room on stress, anxiety, and surgical fear in patients undergoing transurethral resection of bladder tumor (TURBT). Bladder cancer is a common urological malignancy, and psychological problems are frequently observed in the preoperative period. The absence of family support in the operating room may increase anxiety and fear, triggering physiological stress responses and raising the risk of complications.\n\nThis multicenter randomized controlled trial will be conducted between September 2025 and March 2027 at Bitlis State Hospital and Tatvan State Hospital. The study sample will include 128 eligible patients, randomly assigned to intervention and control groups. Patients in the intervention group will have a video call with a designated family member in the operating room, while control group patients will receive routine care.\n\nData will be collected using the Descriptive Information Form, the Surgical Fear Questionnaire, and the Visual Analogue Scale; stress levels will be assessed through serum cortisol and glucose values. Measurements will be taken at three time points: preoperatively (T0), immediately before anesthesia (T1), and on the first postoperative day (T2).\n\nThe study is expected to demonstrate that maintaining family support through video calls in the preoperative period reduces anxiety, fear, and stress, thereby improving surgical outcomes and contributing to the development of family-centered care practices.",[445,28],"Bladder Tumor (TURBT)",[447,448,449,450,451],"Transurethral resection of bladder tumor (TURBT)","Preoperative anxiety","Surgical fear","Family-centered care","Video call intervention","2025-09-24",{"date":454,"type":49},"2025-10-02",{"date":456,"type":20},"2025-10-01",{"date":458,"type":20},"2027-09-15",{"name":460,"class":56},"Bitlis Eren University",{"id":462,"slug":4,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":21,"phases":469,"briefSummary":470,"conditions":471,"keywords":472,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":484,"locationsCount":84},"100603875","NCT07142200","A Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin Combined With PD-1 Inhibitor and Radiotherapy as Bladder-preserving Therapy in Patients With Localized HER2-high Expressing Muscle-invasive Bladder Urothelial Carcinoma Following Maximal Transurethral Resection","DECIDING","Inclusion Criteria:\n\n* Men or women aged ≥ 18 years old;\n* ECOG PS:0～1;\n* The subjects need to undergo maximum TURBT surgery (no need for secondary resection) and imaging diagnosis. The researchers have determined that MIBC (urothelial carcinoma as the main pathological component\\>50%) is present, and plan to undergo radical cystectomy, lymph node dissection, and urinary diversion surgery;\n* cT2-T4a N0 M0 （CT\u002FMRI ± PET\u002FCT）;\n* Accept maximum TURBT;\n* Have tissue examination specimens with TURBT;\n* Expected survival period ≥ 3 months;\n* The immunohistochemical staining result of the tissue after the last TURBT surgery was IHC 2+or 3+;\n* The main organ function is normal (14 days before enrollment), which meets the following criteria:\n\n  1. The standard for blood routine examination must meet the following criteria: (no blood transfusion or treatment with granulocyte colony-stimulating factor within 14 days before enrollment):\n\n     HB≥90 g\u002FL； ANC≥1.5×109 \u002FL； PLT≥100×109 \u002FL；\n  2. Non functional organic diseases must meet the following criteria:\n\nT-BIL ≤ 1.5 × ULN (upper limit of normal value); ALT and AST ≤ 2.5 × ULN; If there is liver metastasis, ALT and AST should be ≤ 5 × ULN; Blood creatinine ≤ 1.5 × ULN or creatinine clearance rate (CrCl) calculated according to the Cockcroft Gault formula ≥ 50 mL\u002Fmin; International normalized ratio (INR) and activated partial thromboplastin time (aPTT): ≤ 1.5 × ULN (this standard is only applicable to patients who have not received anticoagulant therapy); Patients receiving anticoagulant therapy should ensure that the anticoagulant is within the required treatment range;\n\n* Have not received systemic corticosteroid treatment within 4 weeks prior to treatment;\n* Men with reproductive ability or women with the possibility of pregnancy must use highly effective contraceptive methods during the trial (such as oral contraceptives, intrauterine devices, abstinence control or barrier contraception combined with spermicides), and continue contraception for 12 months after the end of treatment;\n* The subjects voluntarily joined the study, signed informed consent forms, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n* Previous treatment with anti-PD-1, anti-PD-L1, and anti-PD-L2, including adjuvant therapy phase;\n* Individuals known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components;\n* Those who have received systemic chemotherapy, radiation therapy, or other anti-tumor treatments (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of treatment, or have not yet recovered from the previous toxicity (excluding 2nd degree hair loss and 1st degree neurotoxicity);\n* Pregnant or lactating women;\n* Positive HIV test result;\n* Active hepatitis B or C patients HBsAg or HBcAb positive individuals were simultaneously detected with HBV DNA copy number positivity (quantitative detection limit is 500IU\u002Fml, or reaching the copy number positivity value detected by the research center); Patients of this type must undergo HBV DNA testing during screening studies; Patients with positive HCV antibody test results are only eligible for this study if their HCV RNA PCR test results are negative;\n* Have a clear history of active tuberculosis;\n* Active autoimmune diseases that require systematic treatment within the past 2 years (such as the use of disease regulating drugs, corticosteroids, or immunosuppressive drugs), allowing for related alternative treatments (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for renal or pituitary dysfunction);\n* Other serious and uncontrollable concomitant diseases that may affect the compliance of the scheme or interfere with the interpretation of the results, including active opportunistic infections or progressive (serious) infections, uncontrollable diabetes, cardiovascular diseases (Grade III or IV heart failure defined by the New York Heart Association classification, Grade II or above heart block, myocardial infarction, unstable arrhythmia or unstable angina pectoris in the past six months, cerebral infarction in three months, etc.) or lung diseases (interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm history);\n* Previously received live vaccination within 4 weeks before the start of treatment;\n* Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n* Significant surgical procedures (excluding diagnostic surgeries or TURBT) performed within the 4 weeks prior to the start of treatment;\n* Individuals with a history of substance abuse and inability to quit, or those with a history of mental disorders;\n* Large amounts of pleural or ascites accompanied by clinical symptoms or requiring symptomatic treatment;\n* In the past 5 years, have had other malignant tumors that have not been cured, but do not include malignant tumors that have been clearly cured, or curable cancers such as basal or squamous cell carcinoma, localized low-risk prostate cancer, cervical in situ cancer, or breast in situ cancer; Note: Localized low-risk prostate cancer (defined as patients with stage ≤ T2b, Gleason score ≤ 7, and PSA ≤ 20ng\u002FmL (as measured) at the time of prostate cancer diagnosis who have received curative treatment and have no biochemical recurrence of prostate-specific antigen (PSA) may participate in this study);\n* Simultaneous presence of upper urinary tract urothelial carcinoma (renal pelvis, ureteral urothelial carcinoma);\n* According to the researcher's perspective, there may be increased risks associated with participating in the study, or other severe, acute, or chronic medical or mental illnesses or laboratory abnormalities that may interfere with the interpretation of the research results.",{"count":468,"type":20},45,[125],"This is a prospective, open label, multicenter clinical study of vediximab combined with PD-1 and radiation therapy for bladder preservation in MIBC patients with HER-2 high expression (IHC 2+or 3+), conducted in accordance with Good Clinical Practice (GCP).\n\nEach patient received treatment with Vediximab injection \\[2.0 mg\u002Fkg, Q2W, iv\\] and Triprolizumab injection \\[3mg\u002Fkg, Q2W, iv\\] for one cycle, followed by concurrent radiotherapy in the second cycle. Assuming a 20% improvement in the efficacy of conventional TMT bladder protection treatment, i.e. an increase in CR rate from 60% to 80%, alpha of 0.05, and beta of 0.2, a sample size of 36 is required. Considering a 20% dropout rate, 45 subjects need to be enrolled.\n\nThe subjects need to undergo maximum transurethral resection of the bladder (TURBT) and imaging diagnosis, and collect urine samples before treatment. The researchers judged that localized myometrial invasive bladder cancer with high HER2 expression could be treated with bladder conserving therapy by maximizing TURBT. The patient will receive treatment with vediximab combined with PD-1 and radiotherapy after TURBT surgery (without the need for secondary resection).\n\nThe subjects should receive treatment with vediximab combined with PD-1 every two weeks for a total of 12 treatment cycles, and receive radiation therapy simultaneously. The specific number of treatment cycles will be determined by the researchers based on the patient's response to the treatment, tolerance to the regimen, and overall judgment of the condition. Patients with safety intolerance caused by any drug treatment will be reduced or discontinued according to the dosage adjustment plan specified in the regimen.\n\nAfter completing the above treatments, the pathology, imaging, and cytology of the tumor site were obtained through diagnostic TURBT or cystoscopy for tumor evaluation to assess whether complete remission was achieved. The first tumor efficacy evaluation was conducted 3 months after receiving treatment, and the researcher judged whether to continue treatment based on the patient's treatment status. After completing the treatment for the next 3 months, another tumor efficacy evaluation was conducted. After completing all 12 treatment cycles (6 months), the patient underwent two tumor evaluations at the 6th month (from the 12th month of treatment) and the 12th month (from the 24th month of treatment), respectively.",[28],[473,474,475,476,477],"muscle-invasive bladder cancer","Disitamab Vedotin","PD-1 Inhibitor","Radiotherapy","Bladder-preserving Therapy","2025-08-24",{"date":480,"type":49},"2025-08-26",{"date":482,"type":20},"2025-09-01",{"date":350,"type":20},{"name":352,"class":56},{"id":486,"slug":4,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":21,"phases":493,"briefSummary":494,"conditions":495,"keywords":500,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":84},"100598150","NCT07067749","Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer","TEMPO-MIBC","Inclusion Criteria:\n\n* Clinical suspicion of muscle invasive bladder cancer at cystoscopy and pre-cystoscopy imaging\n\nExclusion Criteria:\n\n* Anticipated survival \\\u003C 3 months due to comorbidities\n* Pregnant patients\n* Breastfeeding patients\n* Previous chemotherapy within 6 weeks\n* Previous radiotherapy withing 6 weeks\n* Previous TURBt within 6 weeks\n* Severe renal impairment (eGFR \\\u003C 40 mL\u002Fmin\u002F1.73 m2)\n* non MRI-compatible metal implants\n* Claustrophobia\n* Denial of written consent to participate in the study",{"count":492,"type":20},92,[95],"The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer (MIBC). This study investigates the role of multiparametric bladder MRI (mpMRI) in patients with biopsy proven cancer of the bladder with clinical features of detrusor muscle invasion. In the experimental arm, enrolled patients will receive a bladder mpMRI, if this exam will confirm the high suspicion of muscle invasion a conventional endoscopic transurethral resection of bladder tumour (TURBt) for staging purposes will be foregone and patients will immediately access the next step of their clinical management. Experimental arm outcomes will be compared to a control arm in which all enrolled patients will be receiving TURBt as part of the standard management of bladder cancer. The aim of this study is demonstrating a significant reduction of the time needed to offer patients the definitive treatment for their disease, possibly ensuring better long-term oncological outcomes.\n\nA blood sample will be collected from each patient enrolled in the study at pre-planned time points to measure the levels of circulating tumour (ctDNA), a primer will be built from bladder cancer biopsies performed at enrolment. ctDNA has been shown to be a proxy measure of tumour burden and residual molecular disease after treatment. The ctDNA levels in the experimental arm will be compared to those of the control arm to investigate wether foregoing endoscopic resection of the tumour and reducing time to definitive cancer treatment might be associated to lower ctDNA levels.",[28,496,497,498,499],"Bladder Cancer Requiring Cystectomy","Bladder Carcinoma","Bladder Neoplasm","Muscle Invasive Bladder Cancer (MIBC)",[501,502,503,504,187,505,506,507],"Muscle Invasive Bladder Cancer","VI-RADS","Bladder Magnetic Resonance Imaging","Cystectomy","treatment expedition","cancer management optimisation","circulating tumour DNA","2025-07-19",{"date":510,"type":49},"2025-07-24",{"date":512,"type":20},"2025-08-15",{"date":514,"type":20},"2030-08-15",{"name":516,"class":56},"University of Rome Tor Vergata",{"id":518,"slug":4,"hasResults":11,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":11,"sex":16,"minAge":360,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":21,"phases":526,"briefSummary":527,"conditions":528,"keywords":530,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":540,"leadSponsor":542,"locationsCount":84},"100597928","NCT07064863","A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.","BCG-TIME: Improving Response to Bacillus Calmette Guerin Immunotherapy in High-risk Non-muscle Invasive Bladder Cancer Via a Tumor Immune MicroEnvironment Based Biomarker.","BCG-TIME","Inclusion Criteria:\n\n* Patients with an initial diagnosis of NMIBC without previous exposure to BCG immunotherapy (BCG-naive).\n* Patients with pathologic diagnosis of Ta or T1 high grade NMIBC with or without CIS.\n* Participants older than 65 years of age.\n\nExclusion Criteria:\n\n* Patients with prior exposure to BCG immunotherapy.\n* Immunosuppressed patients on steroids, transplants etc.",{"count":525,"type":20},31,[67,125],"This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive bladder cancer. Responses will be compared between patients with high-risk NMIBC who are being treated with standard of care BCG therapy and those treated with combination chemotherapy. Local and systemic immune monitoring assays will allow early identification of patients who will not benefit from BCG immunotherapy.",[244,529,28,240],"Non-Muscle Invasive Bladder Urothelial Carcinoma",[423,244,531,532,533,534,535],"Gemcitabine","Tumor Immune MicroEnvironment","Systemic immunity","Mucosal immune response","Immune Biomarker","2025-07-14",{"date":538,"type":49},"2025-07-17",{"date":79,"type":20},{"date":541,"type":20},"2027-07-31",{"name":543,"class":56},"Queen's University",{"id":545,"slug":4,"hasResults":11,"nctId":546,"briefTitle":547,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":549,"targetDuration":550,"studyType":178,"phases":4,"briefSummary":551,"conditions":552,"keywords":553,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":4},"100597071","NCT07053722","Observational Clinical Study of Patients With Muscle - Invasive Bladder Cancer Undergoing Bladder Preservation Therapy After Neoadjuvant Therapy","Inclusion Criteria:\n\nHistopathologically confirmed bladder cancer (T2-T4aN0-2M0, 8th edition AJCC staging).\n\nUnderwent bladder - sparing TMT following neoadjuvant therapy (ADC, immunotherapy, or chemotherapy).\n\nAged ≥18 years. Signed an informed consent form. Good general condition with ECOG performance status of 0-2. Adequate organ function for chemoradiotherapy: (1) Hematology: Absolute neutrophil count ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL. (2) Liver function: Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (≤5×ULN if hepatic metastasis is present). (3) Renal function: Creatinine clearance ≥30 mL\u002Fmin (via Cockcroft-Gault formula).\n\nExclusion Criteria:\n\nDistant metastasis (M1). Other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ).\n\nSevere cardiovascular disease (uncontrolled heart failure, unstable angina, myocardial infarction, etc.).\n\nSevere hepatic\u002Frenal dysfunction intolerance to chemoradiotherapy. Mental illness\u002Fcognitive impairment unable to comply with the study. Allergy to chemoradiotherapy drugs. Pregnant or breastfeeding women. Previous pelvic radiotherapy.",{"count":211,"type":20},"5 Years","The goal of this observational study is to evaluate the safety and efficacy of neoadjuvant therapy followed by bladder - preserving TMT in patients with MIBC. The main question it aims to answer is: Does this treatment model improve long - term outcomes, including survival, local control, distant metastasis, and bladder preservation rates? Participants who received neoadjuvant therapy and underwent TMT for bladder preservation will be observed.",[28],[554,103,555],"radiation oncology","TMT","2025-06-27",{"date":558,"type":49},"2025-07-08",{"date":560,"type":20},"2025-06-30",{"date":562,"type":20},"2027-06-30",{"name":564,"class":56},"Peking University First Hospital",{"id":566,"slug":4,"hasResults":11,"nctId":567,"briefTitle":568,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":21,"phases":571,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":577,"leadSponsor":578,"locationsCount":4},"100597072","NCT07053735","An Exploratory Clinical Study of Nimotuzumab in Bladder - Sparing Chemoradiotherapy for Muscle - Invasive Bladder Cancer","Inclusion Criteria:\n\nSigned informed consent. Aged ≥18. Histologically confirmed urothelial carcinoma of the bladder, staged T2a-T4a, anyN, M0, or recurrent T1 high - grade tumors (7th - edition AJCC staging).\n\nUnsuitable or intolerant to cystectomy, or with comorbidities making systemic chemotherapy intolerable, or chemotherapy - averse, or recurrent after prior TURBT and unsuitable for further TURBT or cystectomy.\n\nECOG performance status 0-2. No severe hematopoietic or major organ dysfunction, or immunodeficiency. Pre - enrollment lab values: white blood cell count ≥3.5×10⁹\u002FL, absolute neutrophil count ≥1.5×10⁹\u002FL, platelets ≥50×10⁹\u002FL, hemoglobin ≥90 g\u002FL; renal: serum creatinine ≤1.2 mg\u002FdL or creatinine clearance ≥60 mL\u002Fmin; hepatic: total bilirubin ≤3.0×ULN, AST\u002FALT ≤2.0×ULN; coagulation: INR ≤2.0.\n\nAgreed contraception during the trial for fertile individuals; females of childbearing potential must have a negative pregnancy test within 7 days before initial dosing.\n\nNo prior chemotherapy, targeted, or immunotherapy for cancer.\n\nExclusion Criteria:\n\nMetastatic cancer. Previous pelvic\u002Fabdominal radiotherapy. Uncontrolled infection, intractable epilepsy, high intracranial pressure, hypertension, hyperglycemia, angina (Grade 1\u002Fsymptomatic\u002F≥Grade 2), peripheral neuropathy, or a history of myocardial infarction\u002Fheart failure within 6 months, or jaundice due to hepatic insufficiency.\n\nHIV, active hepatitis B (HBsAg and HBV - DNA positive), or active hepatitis C (HCV - RNA positive).\n\nMajor surgery within 4 weeks before enrollment. Participation in another clinical trial within 4 weeks before enrollment. Other uncontrolled malignancies within the past 5 years (except cervical in - situ carcinoma, squamous cell skin cancer, or localized basal cell carcinoma).\n\nAny other researcher - identified reason making participation unsuitable.",{"count":211,"type":20},[67],"The goal of this exploratory study is to evaluate the safety and efficacy of nimotuzumab combined with chemoradiotherapy in bladder - preserving treatment for MIBC patients who are ineligible for or decline radical cystectomy. The main questions it aims to answer are:\n\nDoes nimotuzumab combined with radiotherapy reduce adverse events in elderly bladder cancer patients? Does this combination improve objective response rate (ORR), progression - free survival (PFS), overall survival (OS), and bladder preservation rate in these patients? Participants will be MIBC patients treated with nimotuzumab and chemoradiotherapy, with a planned 5 - year follow - up to assess treatment efficacy and safety.",[28],[103,555,554],{"date":558,"type":49},{"date":560,"type":20},{"date":562,"type":20},{"name":564,"class":56},{"id":580,"slug":4,"hasResults":11,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":21,"phases":588,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":84},"100594421","NCT07019220","Chemoablation for Low-Grade Bladder Cancer","COBRA - Chemoablation for Low Grade Bladder Cancer: A Single Arm, Prospective, Open-label, Investigator-initiated Phase 2 Study","COBRA","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study\n* Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening\n* On screening cystoscopy: Diameter of the largest lesion ≤15mm\n* Number of lesions ≤5\n* Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation\n* Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk)\n* NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT)\n* Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening\n* No lymph node metastasis or distant metastasis\n* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment\n* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Female patients of childbearing potential must use adequate contraception during study period\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Tumors that clinicians suspect to be HG\n* Positive HG cytology according to Paris criteria\n* Diameter of tumor \\>15 mm\n* Number of lesions \\>5\n* Any previous intravesical therapy within 1 year\n* Previous HG NMIBC (within the last 3 years). It is allowed to include patients who had history of HG disease longer than 3 years ago.\n* Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC\n* History of upper tract urothelial carcinoma (UTUC)\n* Clinically significant urethral stricture that would preclude passage of a urethral catheter\n* History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding\n* Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and\u002For administration of study treatment\n* Patient refused to participate\n* Known positive human immunodeficiency virus (HIV) test.\n* Female patients who are pregnant\u002Fbreastfeeding.\n* Female patients of childbearing potential not using adequate contraception.",{"count":587,"type":20},47,[125],"The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.",[28],[592,593,594],"Non-Muscle Invasive Bladder Cancer","Intravesical Therapy","Non-Surgical Treatment","2025-06-12",{"date":597,"type":49},"2025-06-13",{"date":599,"type":49},"2023-12-27",{"date":601,"type":20},"2027-11",{"name":603,"class":56},"Ekaterina Laukhtina",{"id":605,"slug":4,"hasResults":11,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":11,"sex":16,"minAge":610,"maxAge":611,"enrollmentInfo":612,"targetDuration":4,"studyType":21,"phases":614,"briefSummary":615,"conditions":616,"keywords":619,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":626,"leadSponsor":628,"locationsCount":84},"100591612","NCT06982690","Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial","Impact of Anesthesia Modality on Recurrence and Progression in High-Risk Non-Muscle Invasive Bladder Cancer: A Randomized Controlled Trial Comparing Spinal Versus General Anesthesia","Inclusion Criteria:\n\n* Age ≥40 years for male subjects or postmenopausal female subjects\n* ECOG performance status 0-2\n* Patients with suspected or newly diagnosed UBUC\n* ASA I or II\n* Patients with any other adequately treated Stage I or II cancer except UC, from which the subject has been disease free for 5 years\n* Adequate renal function, defined as a serum creatinine (Cre) concentration ≤ the institutional ULN\n* Adequate hepatic function, defined as total bilirubin ≤ the institutional ULN and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ the institutional upper limit of normal (ULN)\n\nExclusion Criteria:\n\n* Patients with prior or concurrent UC involving the renal pelvis, ureter or urethra\n* Patients with clinical evidence of MIBC or mUC\n* Immunocompromised or immunosuppressed patients\n* Patients with chronic use of anti-inflammatory agents or beta-blockers\n* Patients with difficult airways or other significant cardiovascular comorbidities (severe aortic stenosis, significant pulmonary disease, CHF) who are intolerant to GA\n* Patients with elevated intracranial pressure (ICP), primarily due to intracranial mass and trauma or infection at the site of SA\n* Patients with a serious uncontrolled medical disorder (e.g., trauma, fracture) or active infection that would impair their ability to receive spinal or GA\n* Patients with known allergies to propofol, fentanyl, sevoflurane, or bupivacaine\n* Subjects with a known history or family history of malignant hyperthermia\n* Subjects with bleeding diathesis","20 Years","80 Years",{"count":613,"type":20},370,[23],"To demonstrate the superior efficacy of spinal anesthesia (SA) versus general anesthesia (GA) according to the delay of time to recurrence in high-risk NMIBC patients up to Week 104 after TURBT.",[244,187,28,181,617,618],"Anesthesia, General","Anesthesia,Spinal",[103,620,621,193,187],"general anesthesia","spinal anesthesia","2025-05-13",{"date":624,"type":49},"2025-05-21",{"date":79,"type":20},{"date":627,"type":20},"2029-11-30",{"name":629,"class":56},"National Taiwan University Hospital",{"id":631,"slug":4,"hasResults":11,"nctId":632,"briefTitle":633,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":21,"phases":637,"briefSummary":638,"conditions":639,"keywords":4,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":650,"leadSponsor":652,"locationsCount":84},"100576273","NCT06783153","Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients","Inclusion Criteria:\n\n* Individuals who are 18 years of age or older and have been diagnosed with non metastatic pelvic cancers.\n* Patients who are undergoing curative intent radiotherapy with or without chemotherapy treatment.\n\nExclusion Criteria:\n\n* Patients who have a record of intestinal resection in their medical history.\n* Patients with a medical background of irritable bowel syndrome.\n* Patients with a history of inflammatory bowel disease.\n* Patients who regularly take anti-diarrheal medications before commencing radiotherapy.\n* Patients experiencing diarrhea at the outset of the study.\n* Patients with compromised immune systems, such as those who are HIV positive or using immunosuppressive medications.\n* Pregnant or lactating woman.\n* Patients allergic to rifamycin.",{"count":636,"type":20},80,[67,125],"Preclinical data indicate that rifaximin could be repurposed as a novel strategy for preventing and reducing the severity of gastrointestinal damage, particularly diarrhea, that results from pelvic irradiation. So, The aim of the work is to investigate the impact of Rifaximin on the incidence and severity of radiotherapy-induced diarrhea in cancer patients undergoing pelvic irradiation with or without chemotherapy.",[640,641,42,642,28,643,644,645],"Radiotherapy Induced Diarrhea","Acute Radiation Enteritis","Cervical Adenocarcinoma","Rectal Adenocarcinoma","Pelvic Radiotherapy","Rifaximin","2025-01-14",{"date":648,"type":49},"2025-01-20",{"date":648,"type":20},{"date":651,"type":20},"2025-12",{"name":653,"class":56},"Mansoura University",{"id":655,"slug":4,"hasResults":11,"nctId":656,"briefTitle":657,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":660,"targetDuration":4,"studyType":21,"phases":662,"briefSummary":663,"conditions":664,"keywords":667,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":4},"100573852","NCT06751667","Xpert Bladder Monitor: a Non-Invasive Follow-Up Tool for Detecting Relapse in High Grade or High Risk Bladder Cancer","LIBERO","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf\n* NMIBC high grade or high risk (already subjected to or currently undergoing treatment with BCG).\n* No contraindications to surgery\n\nExclusion Criteria:\n\n* Inability or unwillingness of the participant or their legal representative to provide written informed consent\n* Absolute contraindications to surgery or cystoscopy\n* Patients who have previously participated in clinical protocols involving chemotherapy drugs or immunotherapy\n* Patients with multiple recurrent tumors eligible for cystectomy or Muscle-Invasive Bladder Cancer (MIBC)",{"count":661,"type":20},50,[23],"Main objectives:\n\nQualitative and quantitative monitoring of recurrences in patients with a previous diagnosis of high-grade bladder cancer at high risk of persistence\u002Frecurrence.\n\nEndpoints: Presence or absence of mRNA in urine with a dichotomous result; concordance between Xpert BM and histopathological examination\n\nClinical relevance: reduces by half the number of (invasive) cystoscopies during follow-up. The non-invasive nature of the test could improve patient compliance with follow-up. Interventional study because it would reduce by half the number of cystoscopies during follow-up of bladder cancer which is considered the gold standard in the follow-up of this tumor. However, these markers are already CE validated and described in the European guidelines and for this reason the risk would be low.",[28,74,665,181,666],"Bladder Tumors","Cystoscopy",[668,669],"Xpert Bladder Monitor","Gene Xpert","2024-12-20",{"date":672,"type":49},"2024-12-30",{"date":674,"type":20},"2025-01-01",{"date":676,"type":20},"2032-01-01",{"name":678,"class":56},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",""]