[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573852":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":31,"slug":20,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":34,"acronym":35,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":20,"enrollmentInfo":39,"targetDuration":20,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":52,"overallStatus":55,"whyStopped":20,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Alternate cystoscopies and urinary biomarkers Xpert Bladder Monitor","ACTIVE_COMPARATOR","Patients with High Grade or High Risk Bladder Cancer",[13],"Device: Urinary biomarkers",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Urinary biomarkers","In a bid to reduce or replace surveillance cystoscopies multiple urinary biomarkers have been evaluated for the follow-up of the bladder cancer patients. These device will reduce the number of cystoscopies",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Alberto Macchi, Medical Doctor","CONTACT","+39 3381840185","alberto.macchi@istitutotumori.mi.it",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Nicola Nicolai","Doctor","100573852",false,"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)","ALL","18 Years",{"count":40,"type":41},50,"ESTIMATED","INTERVENTIONAL",[44],"NA","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.",[47,48,49,50,51],"Bladder (Urothelial, Transitional Cell) Cancer","Bladder Cancer","Bladder Tumors","Bladder Cancer Recurrence","Cystoscopy",[53,54],"Xpert Bladder Monitor","Gene Xpert","NOT_YET_RECRUITING","2024-12-20",{"date":58,"type":59},"2024-12-30","ACTUAL",{"date":61,"type":41},"2025-01-01",{"date":63,"type":41},"2032-01-01",{"name":5,"class":6}]