[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"St. Jude Children's Research Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":610},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,98,0,25,[9,44,66,90,114,137,158,180,204,222,232,254,278,299,320,343,366,390,407,431,448,465,492,562,589],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":24,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053322",false,"NCT07314736","Stakeholders of Rare Diseases Informing Values In Neuroethics","Inclusion Criteria:\n\nGroup 1 (Parental Caregiver and Patient Participants)\n\n* Parental\u002Fprimary caregiver with a child who has a genetic diagnosis of an ultrarare disorder with pediatric onset, or a clinical diagnosis with a suspected genetic etiology.\n* Child is under 21 years of age at the time of enrollment.\n* Child has an expected survival of at least one year following study enrollment.\n* Patients (age ≤ 25 years) with a genetic diagnosis of an ultrarare disorder with pediatric onset, or clinical diagnosis with suspected genetic etiology.\n* Willingness to provide verbal informed consent (or assent, as appropriate) to participate\n\nGroup 2 (Other Family)\n\n* Family member of a Group 1 participant who plays an active role in the child's life or care.\n* Includes siblings (≥ 13 years of age), grandparents, or other non-primary caregivers directly affected by the child's diagnosis.\n* Demonstrated familiarity with the child's medical and family experience.\n* Willingness to provide verbal informed consent (or assent, as appropriate) to participate.\n\nGroup 3 (Non-Family Stakeholders)\n\n* Individuals currently engaged, or recently active, in clinical care, research, advocacy or policy work related to pediatric-onset rare genetic disorders.\n* May include clinicians (e.g., neurologists, genetic counselors, nurses, child-life specialists, home-health staff), members of patient-advocacy organizations, institutional-review-board (IRB) members, payers, sponsors, funders, or representatives of hospital systems or regulatory agencies.\n* Willingness to provide verbal informed consent to participate in semi-structured interviews or focus groups\n\nExclusion Criteria:\n\n* Limited English proficiency\n* Unable to complete the survey materials or complete the interviews in English.\n* Inability or unwillingness of research participant to give verbal informed consent (in English)\n* Condition or chronic illness, which in the opinion of the PI\u002FCo-I, makes participation unsafe or untenable (i.e., cognitive impairment, concurrent acute morbidity).","ALL",{"count":17,"type":18},385,"ESTIMATED","OBSERVATIONAL","The purpose of this research study is to learn more about the perspectives of key stakeholders-patients, families, healthcare providers, and researchers-on the ethical challenges of small-scale, personalized treatment trials for rare neurological diseases (RND).",[22,23],"Rare Disorder","Disorder, Neurologic",[25,26,27,28,29,30],"Rare Neurological Disorders (RND)","Stakeholders","Patient Participant","Caregiver","Other Family","Non-Family Stakeholder","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2026-07-08",{"date":39,"type":18},"2031-01",{"name":41,"class":42},"St. Jude Children's Research Hospital","OTHER",1,{"id":45,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":43},"100053353","NCT07071116","Seminar in Unwavering Empowering Presence Optimized for Rehabilitation Teams","Inclusion Criteria: Intervention Participants\n\n* Licensed rehabilitation professionals (e.g., physical therapists, occupational therapists, speech-language pathologists) employed at St. Jude Children's Research Hospital actively involved in the care of pediatric oncology patients.\n* Willingness to participate in the communication skills training (CST) intervention and associated study activities.\n\nInclusion Criteria: Intervention Facilitators\n\n* St. Jude Bereaved Parent Educators who have participated as an educator in at least one other institutional educational event\n* Willingness to facilitate the communication skills training (CST) intervention and complete associated study activities.\n\nExclusion Criteria: Intervention Participants\n\n* Non-rehabilitation professionals\n* Individuals unable to attend the CST intervention session.\n\nExclusion Criteria: Intervention Facilitators\n\n* Individuals unable to attend the CST intervention session.",true,{"count":7,"type":18},"INTERVENTIONAL",[53],"NA","The goal of this study to test the feasibility, acceptability, and potential impact of a serious illness communication skills training (CST) tailored to rehabilitation professionals to improve their comfort and confidence in navigating difficult conversations with patients and families.\n\nPrimary Objectives:\n\nAim 1: To assess feasibility and acceptability of a multidisciplinary co-designed interactive CST program for rehabilitation professionals who care for children with serious illness and their families.\n\nAim 2: To characterize the potential impact of this CST intervention on pediatric rehabilitation professionals.\n\nSecondary Objective:\n\nAim 3: To examine the perspectives of bereaved parent educators on participation in the implementation of communication training for rehabilitation professionals.",[56],"Communication",[58,59],"Communication Skills Training (CST)","Rehabilitation Professionals",{"date":34,"type":35},{"date":62,"type":35},"2025-07-09",{"date":64,"type":18},"2028-10",{"name":41,"class":42},{"id":67,"slug":4,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":15,"minAge":72,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":43},"100644398","NCT07663539","Insights From Bereaved Parents and Oncologists","Foundations of Communication in Uncertainty Study (FOCUS): Insights From Bereaved Parents and Oncologists","Inclusion Criteria:\n\n* All participants must be ≥ 18 years of age or legally emancipated\n* Parent Participants must have a child who:\n\n  * Received cancer care from a clinician at St. Jude, as documented in the electronic medical record, AND\n  * Died at least 6 months prior to enrollment, but no more than 24 months prior to enrollment.\n* Oncologist participants at St. Jude must:\n\n  * Be listed as the primary oncologist as documented in the electronic medical record, AND\n  * Have the respective patient's parent agreement to participate in the study.\n\nExclusion Criteria:\n\n* Declining, refusal, or unwillingness to participate\n* Inability or unwillingness of research participant to give informed consent.","18 Years",{"count":74,"type":18},50,"Investigators want to find better ways for doctors and families to talk about cancer and how uncertainty may affect a child's life.",[56],[78,79,80],"Prognostic Uncertainty","Bereaved Parents","Oncologist","NOT_YET_RECRUITING","2026-07-01",{"date":84,"type":35},"2026-07-02",{"date":86,"type":18},"2026-07",{"date":88,"type":18},"2026-09",{"name":41,"class":42},{"id":91,"slug":4,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":51,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":43},"100632525","NCT07514819","Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Participants diagnosed with solid tumors, including Rhabdomyosarcoma, Osteosarcoma, Ewing sarcoma, other sarcomas and carcinomas or also Hodgkin's lymphoma.\n* Participants who receive proton radiation therapy at St. Jude Children's Research Hospital.\n* Research participant or legal guardian\u002Frepresentative gives written informed consent.\n\nExclusion Criteria:\n\n* Participants who are not diagnosed with solid tumors or Hodgkin's lymphoma.\n* Participants who are diagnosed with Wilm's tumor or neuroblastoma\n* Participants who do not undergo proton therapy.\n* Participants who are prescribed equal or less than 5 fractions of proton therapy.\n* Participants with severe comorbid conditions that may impact imaging feasibility.\n* Inability to obtain written consent from research participant or legal guardian\u002Frepresentative.\n* Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants \\>10 years of age or post-menarchal must have a negative serum or urine pregnancy test\n\nAll participants receiving proton therapy at St. Jude Children's Research Hospital will be screened for participation on this research protocol based on the Inclusion Criteria and the Exclusion Criteria. Qualified candidates will be selected during the consultation.",{"count":96,"type":18},100,[53],"Pediatric patients receiving proton therapy for solid tumors or Hodgkin's lymphoma may experience anatomical changes during treatment that can affect proton therapy accuracy. This prospective single-arm study uses regular low-dose imaging to monitor these changes and adjust treatment plans as needed. Participants will receive weekly or every-other-week CT scans, with MRI when appropriate, to assess whether the original plan remains accurate. Treatment plans will be updated if tumor coverage decreases by more than 5% or if radiation dose to normal tissues increases by more than 10%; otherwise, the original plan will continue. The study aims to determine how often plan adjustments are needed and to identify which disease sites are most likely to experience significant anatomical changes during treatment.\n\nPrimary Objective:\n\n* Define the frequency of replanning necessary to ensure tumor coverage never falls below 95% (or 5% drop) of the prescribed daily dose in participants with intact (gross) tumors to keep the tumor control optimal throughout the multi-week treatment regimen.\n* Define the frequency of replanning necessary to ensure organs-at-risk (critical organs) do not deviate by more than 10% of the initially approved dose constraints to keep the normal tissue complication minimal throughout the multi-week treatment regimen.\n\nSecondary Objectives\n\n* Establish a cone beam CT (CBCT)-based framework for quantifying body surface changes throughout the treatment course. This goal will be achieved by developing a novel algorithm that detects and tracks external anatomical variations longitudinally, without requiring CBCT image enhancement, enabling precise assessment of daily participant setup consistency and anatomical stability.\n* Overcome daily CBCT quality limitations by generating synthetic CT images that accurately represent daily anatomy and support proton dose recalculation or verification planning. This goal will be achieved by developing a hybrid pipeline that integrates deep learning models with the deformable image registration algorithm, trained and validated on disease site-specific data. This will enable precise dose mapping and tissue density estimation, directly supporting adaptive planning decisions without the need of diagnostic- quality CT images.",[100,101,102,103,104,105,106],"Pediatric Solid Tumors","Rhabdomyosarcoma","Ewing Sarcoma","Osteosarcoma","Hodgkin Lymphoma","Bone Tumor","Soft Tissue Sarcoma","2026-06-30",{"date":84,"type":35},{"date":110,"type":18},"2026-08",{"date":112,"type":18},"2031-08",{"name":41,"class":42},{"id":115,"slug":4,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":49,"sex":15,"minAge":72,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":51,"phases":122,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":136,"locationsCount":43},"100644955","NCT07675083","Bereaved Parent Conversations on Hope","Bereaved Parent Conversations on Hope (BeHope)","Inclusion Criteria\n\nIntervention Participants must be:\n\n* Students, observers, trainees, and newly hired clinicians,\n* ≥18 years old,\n* participating in or observing clinical care at St. Jude Children's Research Hospital, and\n* willing to participate in the virtual intervention and associated study activities as learners\n\nIntervention Facilitators must be:\n\n* Bereaved parents,\n* ≥ 18 years old,\n* screened and cleared to volunteer as advisers with St. Jude Children's Research Hospital through Family, Guest and Volunteer Services, and\n* willing to participate in the virtual intervention and associated study activities as a facilitator\n\nExclusion Criteria\n\nIntervention Participants:\n\n* Age \\\u003C 18 years, decline participation, or unable to speak\u002Fwrite in conversational English.\n\nIntervention Facilitators:\n\n* Age \\\u003C 18 years, decline participation, or unable to speak\u002Fwrite in conversational English.",{"count":121,"type":18},75,[53],"This study looks at whether it is possible and helpful to have video call conversations about how hopes can change through the cancer journey between bereaved parents and learners at a children's cancer center.",[125],"Hope",[127,128,129,130,131],"Cancer Journey","St. Jude Children's Research Hospital (SJCRH)","SJCRH Bereaved Parent Advisors","SJCRH Learners","Virtual Intervention","2026-06-29",{"date":107,"type":35},{"date":86,"type":18},{"date":64,"type":18},{"name":41,"class":42},{"id":138,"slug":4,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":155,"leadSponsor":157,"locationsCount":43},"100593560","NCT07008027","Real World Asparaginase Therapy Toxicity","Inclusion Criteria:\n\n* Diagnosis of acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia\n* Enrolled on INITIALL and no more than 10 days after initiation of post-INITIALL therapy\n* Post-INITIALL therapy is:\n\n  * Standard of Care (SOC)\u002FNon Protocol Treatment Plan (NPTP) as per Total therapy or\n  * SJALL23T and not scheduled to receive venetoclax\n\nExclusion Criteria:\n\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.",{"count":143,"type":18},200,"This research study is being done to learn more about the short term and long term side effects of treatment with asparaginase drugs, which are commonly used in acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma (LLy) therapy.",[146],"Drug Toxicity",[148,149,150,151,152],"Asparaginase drugs","Toxicity","Acute lymphoblastic leukemia","Acute lymphoblastic lymphoma","Mixed phenotype acute leukemia",{"date":82,"type":35},{"date":86,"type":18},{"date":156,"type":18},"2031-07",{"name":41,"class":42},{"id":159,"slug":4,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":15,"minAge":164,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":51,"phases":167,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":178,"leadSponsor":179,"locationsCount":43},"100632639","NCT07516301","Feasibility of Incorporating a Standardized Substance Use Measure With Linked-Brief Intervention Into Routine Psychosocial Care of Adult Childhood Cancer Survivors","Piloting the Feasibility of Incorporating a Standardized Substance Use Measure With Linked-Brief Intervention Into Routine Psychosocial Care of Adult Childhood Cancer Survivors","Inclusion Criteria:\n\n* Followed in the ACT Clinic at St. Jude Children's Research Hospital\n* Greater than or equal to 15 years of age at time of evaluation\n* Able to speak and read English\n\nExclusion Criteria:\n\n* Significant mental or cognitive impairment that would impact ability to complete surveys or participate in the brief intervention","15 Years",{"count":166,"type":18},30,[53],"The ASSIST Study is designed to explore whether a brief, evidence based substance use screening and counseling approach can be easily integrated into routine survivorship care at St. Jude Children's Research Hospital.\n\nDuring a regularly scheduled psychosocial visit, participants complete the World Health Organization's Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). This short questionnaire helps identify patterns of use related to tobacco, alcohol, cannabis, prescription medications, and other substances. Survivors whose results show possible risk receive a brief, supportive counseling session during the same appointment. This session uses motivational interviewing techniques to help individuals reflect on their use and consider steps to reduce potential harm.\n\nPrimary Objective:\n\n\\- Assess the feasibility and acceptability of integrating a standardized substance use screening and brief intervention protocol into routine psychosocial workflows within a survivorship clinic.\n\nSecondary Objective:\n\n\\- Evaluate the fidelity of delivering a brief substance use intervention to reduce substance use behaviors among survivors.",[170,171],"Survivors of Childhood Cancer","Substance Use",[173,174],"Adult childhood cancer survivors (ACCS)","Cancer Survivorship","2026-06-25",{"date":132,"type":35},{"date":86,"type":18},{"date":64,"type":18},{"name":41,"class":42},{"id":181,"slug":4,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":49,"sex":15,"minAge":72,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":51,"phases":188,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":43},"100601440","NCT07110519","Positron Emission Tomography (PET) Contrast Agent Kinetics and Safety: [18F]-Fluoromannitol","Inclusion Criteria:\n\nHealthy volunteers, 18-75 years of age.\n\n* Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.\n* Informed consent signed by participant according to the guidelines of the institutional review board.\n\nExclusion Criteria:\n\nInitial Eligibility Exclusion Criteria (Entry to Screening Phase -\n\n* Participant currently has a fever or other symptoms concerning for an active infection or is currently undergoing treatment for an active infection.\n* Participant has been diagnosed and\u002For treated for a known or suspected bacterial infection within the past 60 days.\n* Participant has known disease of the lung, liver, kidneys, gastrointestinal tract, bones\u002Fjoints, or known immune suppression or autoimmune disease that is likely to have active inflammation (examples to exclude: Crohn's disease, COPD; example to i include: well controlled asthma)\n* Participant has prosthetic or indwelling device(s) currently or has had one in the past 60 days.\n* Participant is pregnant or breastfeeding.\n* Use of drugs known to have interaction or be affected by mannitol within 60 days of enrollment.\n* Participant has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol, including being unable to tolerate the PET scan procedures.\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n* Participant is currently participating in another study subject to an IND.\n\nFinal Eligibility Exclusion Criteria (Entry to Study):\n\nAt the time of the Final Eligibility Determination (Imaging Study Visit 1):\n\n* Participant no longer meets one or more of the Inclusion Criteria\n* Participant now fails one or more of the Initial Eligibility Exclusion Criteria\n* Estimated glomerular filtration rate is \\\u003C 45 ml\u002Fminute\u002F1.73m2\n* Positive pregnancy test (females only)\n* One or more of the results from laboratory (hematology, chemistries, inflammatory markers), vital signs, or ECG specified in the schedule of evaluations is outside the normal institutional range AND is clinically significant in the opinion of the investigator.\n\nRe-screening will not be allowed unless the Investigator considers the cause of the initial screen failure to be of an acute and\u002For completely reversible nature.","75 Years",{"count":187,"type":18},10,[189],"EARLY_PHASE1","This is a Phase 0 interventional, non-therapeutic study investigating the biodistribution and safety of \\[18F\\]-fluoromannitol as a radiotracer (a substance used to help detect disease or infection) in Positron Emission Tomography (PET) scans.\n\nThe primary objective of this study is to generate safety data in healthy adult human volunteers. In the future, this tracer may help to determine if a medical problem is infectious in people who have Sickle Cell Disease, cancer or other conditions that impact the immune system, or with people who have joint implants.\n\nPrimary Objective\n\n\\- Generate safety data, biodistribution and perform human organ dosimetry for \\[18F\\]- fluoromannitol as a novel PET tracer.\n\nParticipants will be recruited primarily from St. Jude Children's Research Hospital employees and SJLIFE participants, and from the broader Memphis community if needed.",[192],"Healthy",[192,194,195,196],"Adult","Age 18-75 years","Volunteer",{"date":198,"type":35},"2026-06-26",{"date":200,"type":35},"2025-09-17",{"date":202,"type":18},"2027-05",{"name":41,"class":42},{"id":205,"slug":4,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":15,"minAge":209,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":43},"100552761","NCT06477289","Peripheral Arterial Tonometry and Neurocognition in Sickle Cell Disease","Inclusion Criteria:\n\n* Diagnosed with sickle cell disease of any genotype\n* Participant in the Sickle Cell Clinical Research and Intervention Program\n* Between 12-25 years of age at the time of enrollment\n* English is the primary language\n* Access to an electronic device with WiFi\n\nExclusion Criteria:\n\n* History of an intellectual disability\n* History of a traumatic brain injury or seizure disorder\n* History of a stroke\n* Undergoing potential curative treatment for SCD (stem cell transplant or gene therapy)\n* Currently prescribed an intervention for a sleep disorder\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.","12 Years","25 Years",{"count":212,"type":18},65,"This study will examine sleep disordered breathing and sleep quality in participants (ages 12-25) diagnosed with sickle cell disease of any genotype. We will utilize remote peripheral arterial tonometry (PAT) and questionnaires to evaluate difficulties with sleep. PAT assessments will occur remotely in the homes of participants.\n\nNeurocognitive, behavioral, and neuroimaging evaluations will occur on the same day as a routine clinic visit.\n\nPrimary Objective:\n\nEvaluate the relationship between nocturnal oxyhemoglobin saturation (SpO2) and neurocognitive functioning (working memory and verbal comprehension) in individuals (ages 12-25) diagnosed with sickle cell disease controlling for age, genotype, and social vulnerability.\n\nSecondary Objective:\n\nAssess differences in white matter integrity, silent cerebral infarcts, neuroinflammation, and functional connectivity among individuals (ages 12-25) diagnosed with sickle cell disease with and without sleep disordered breathing after controlling for age.\n\nAssess differences in self- and caregiver-reported mood and pain severity among individuals (ages 12-25) diagnosed with sickle cell disease with and without sleep disordered breathing after controlling for age.\n\nExploratory Objectives:\n\nExplore the relationship between nocturnal oxyhemoglobin saturation (SpO2) and neurocognitive functioning (attention, processing speed, verbal memory, visual memory, motor dexterity) in individuals (ages 12-25) diagnosed with sickle cell disease controlling for age, genotype, and social vulnerability.\n\nAssess the feasibility of an optical imaging tool (Speckle Contrast Optical Spectroscopy - Open-Motion 3.0) to measure cerebral blood flow and blood volume in patients diagnosed with sickle cell disease (ages 12-25).\n\nAssess the concordance between measurement of cerebral blood flow and volume using speckle contrast optical spectroscopy and arterial spin labeling brain MRI.",[215],"Sickle Cell Disease",{"date":132,"type":35},{"date":218,"type":35},"2024-09-16",{"date":220,"type":18},"2028-06",{"name":41,"class":42},{"id":223,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":225,"keywords":226,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":230,"leadSponsor":231,"locationsCount":43},"100617139",{"count":17,"type":18},[22,23],[25,26,27,28,29,30],"2026-06-24",{"date":175,"type":35},{"date":86,"type":18},{"date":39,"type":18},{"name":41,"class":42},{"id":233,"slug":4,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":15,"minAge":238,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":51,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":251,"leadSponsor":253,"locationsCount":43},"100611810","NCT07245420","Evaluation Of Cardiovascular Health Outcomes Among Survivors 2","Evaluation Of Cardiovascular Health Outcomes Among Survivors 2 (ECHOS2)","Inclusion Criteria:\n\n* Childhood Cancer Survivor Study (CCSS) Participants\n* Age ≥26 years\n* Treated with cumulative doxorubicin equivalent anthracycline doses ≥100 mg\u002Fm2 with any\u002Fno radiation, or ≥15 Gy chest radiation with any\u002Fno anthracyclines\n* No history of cardiomyopathy\n* Has not had an echocardiogram in the previous 5 years\n* Has a history of successful completion of CCSS surveys\n* English-Speaking\n* Has not been enrolled in ECHOS-1 (pilot)\n\nExclusion Criteria:\n\n• Currently participating in a long-term follow-up program that provides risk-based screening","26 Years",{"count":240,"type":18},350,[53],"Childhood cancer survivors who received certain treatments are at a higher risk of developing heart problems in the future. This study is looking at ways to educate childhood cancer survivors about that risk and encourage them to receive a recommended heart screening test.",[244],"Health Behavior",[246,247,248],"Childhood Cancer Survivors","Cardiomyopathy Screening","eHealth Intervention",{"date":198,"type":35},{"date":88,"type":18},{"date":252,"type":18},"2030-12",{"name":41,"class":42},{"id":255,"slug":4,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":49,"sex":15,"minAge":72,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":261,"conditions":262,"keywords":266,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":43},"100633808","NCT07531498","Muscle Aging Phenotypes in Childhood Cancer Survivors","Inclusion Criteria:\n\n* Age 18 years old or older at time of consent and enrolled in SJLIFE.\n* Participant (100 per group for a total of 400) is\u002Fhas:\n* Group 1: No cancer history\n* Group 2: Age and sex specific relative lean mass z-score of less than -0.5 OR age and sex specific hand grip or isokinetic (60 degrees\u002Fsec) quadriceps strength z-score of \\\u003C-0.5 AND exposure to a peripheral neurotoxin.\n* Group 3: Age and sex specific relative lean mass z-score of less than -0.5 OR age and sex specific hand grip or isokinetic (60 degrees\u002Fsec) quadriceps strength z-score of \\\u003C-0.5 AND NOT exposed to a peripheral neurotoxin.\n* Group 4: Age and sex specific relative lean mass z-score of less than -0.5 AND age and sex specific hand grip strength or isokinetic (60 degrees\u002Fsec) quadriceps strength z-score of \\\u003C-0.5 REGARDLESS of exposure status.\n* Participant or legal guardian is able and willing to give informed consent.\n\nExclusion Criteria:\n\n* Presence of implanted medical devices or metal that would interfere with MRI or MRS.\n* Female Participant is pregnant.\n* Body weight exceeding 300 pounds, due to MRI restrictions.\n* Inability to lie flat on his\u002Fher back for 90 minutes or longer for MRI.\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.",{"count":260,"type":18},533,"Childhood cancer survivors experience premature declines in muscle mass, strength, and physical function that contribute to morbidity and early mortality. The biological mechanisms driving these impairments are heterogeneous and poorly understood. This observational study aims to characterize distinct muscle health endotypes in adult survivors of childhood cancer using advanced imaging, neuromuscular testing, and functional assessment. Survivors with reduced muscle health and community controls will undergo multimodal magnetic resonance imaging and spectroscopy, nerve conduction studies, surface electromyography, body composition assessment, and physical performance testing during a single study visit integrated into an ongoing cohort evaluation. Identifying mechanistic endotypes of impaired muscle health will support development of targeted interventions to preserve function and improve long-term outcomes in childhood cancer survivors.\n\nPrimary Objective:\n\n\\- Characterize reduced muscle health endotypes in childhood cancer survivors.\n\nSecondary Objective:\n\n\\- Identify specific treatment and lifestyle related risk factors for each reduced muscle health endotype.\n\nExploratory Objective:\n\n\\- Host germline genetics will be associated with specific muscle endotypes.",[263,264,265],"Muscle Weakness","Low Muscle Mass","Sarcopenia",[246,267,268,269],"Adult Survivors of Childhood Cancer","Neuromuscular Function","Muscle Health","2026-06-22",{"date":272,"type":35},"2026-06-23",{"date":274,"type":18},"2026-10-01",{"date":276,"type":18},"2031-05",{"name":41,"class":42},{"id":279,"slug":4,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":49,"sex":15,"minAge":283,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":296,"leadSponsor":298,"locationsCount":43},"100631607","NCT07502885","Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients","Inclusion Criteria\n\nCases:\n\n* Participant requiring orthopedic surgery due to a diagnosis of lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis (Appendix III) and will receive further additional treatment and\u002For follow-up care at St. Jude.\n* Participant is between the ages of ≥5 and ≤20 years old at the time of enrollment.\n\nControls:\n\n* Participant is between the ages of ≥5 and ≤20 years old at the time of enrollment.\n* Participant (or their parent\u002Flegal guardian) considers themself healthy for their age.\n* Participant (or their parent\u002Flegal guardian) reports being able to participate in normal daily activities of life with respect to their age.\n\nExclusion Criteria\n\nCases:\n\n* Individuals with pre-existing genetic\u002Fcongenital disorders affecting gait will be excluded e.g., cerebral palsy.\n* Individuals who are unable to follow age-appropriate instructions during the gait assessment.\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n* Individuals diagnosed with radiation-induced avascular necrosis.\n\nControls:\n\n* Individuals who are unable to follow age-appropriate instructions during the gait assessment.\n* Individuals who self-report health conditions affecting gait and mobility.\n* Individuals who have the following conditions: diabetes mellitus due to impaired circulation, sensation and strength, malignant cancers, demyelinating inflammatory and degenerative neurological conditions, pregnancy, obesity (BMI \\>40 kg\u002Fm2), severe cardiac or pulmonary disease affecting performance of daily activities, history of major surgery affecting gait and mobility, infections or inflammatory arthropathies, severe mobility impairment necessitating dependence on mobility aids for all ambulation.\n* Individual or legal guardian\u002Frepresentative is unable or unwilling to give written informed consent.","5 Years","20 Years",{"count":286,"type":18},300,"The goal of DEEPGAIT study is to determine how serious walking problems are for pediatric cancer patients who have had orthopedic surgery, how they change over time, and what can be done to help. Healthy participants without cancer will also be included in this study in order to better understand the difference in walking problems between the 2 groups.\n\nDEEPGAIT is a long term study that uses advanced tools-including 3D motion capture, muscle sensors, force plates, and wearable devices-to take a detailed look at how these patients move. Their results are compared to healthy children of the same age and sex.\n\nPRIMARY OBJECTIVES\n\n* Characterize gait deficits in pediatric cancer patients 1 year following orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis.\n* Identify personal, disease, treatment and environment risk factors for gait deficits in pediatric cancer patients 1 year following orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis.\n\nSECONDARY OBJECTIVES\n\n* Build a library of broadly representative normative reference values to generate age- and sex-matched z-scores to quantify frequency, severity and progression of gait deficits among pediatric cancer patients in relation to healthy controls.\n* Characterize the changes of gait parameters in pediatric cancer patients with or without gait deficits 1 year after orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis, up to 5 years after surgery.\n* Identify personal, disease, treatment and environment risk factors for trajectories of gait deficits in pediatric cancer patients with or without gait deficits 1 year after orthopedic surgery for lower limb bone sarcoma, soft tissue sarcoma, or steroid-induced avascular necrosis, up to 5 years after surgery.",[289,290,291],"Sarcoma, Bone","Sarcoma, Soft Tissue","Gait Disorder","2026-06-16",{"date":294,"type":35},"2026-06-18",{"date":292,"type":35},{"date":297,"type":18},"2032-01",{"name":41,"class":42},{"id":300,"slug":4,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":15,"minAge":72,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":307,"conditions":308,"keywords":310,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":317,"leadSponsor":319,"locationsCount":43},"100628074","NCT07456904","Outcomes of Health Care Transition for AYA With a Cancer Predisposition","OnTRAC","Inclusion Criteria:\n\n* Participants are ≥18 years of age\n* Participants with a molecular or clinical diagnosis of a Cancer Predisposition Syndrome (CPS) who are graduating or have graduated from SJCRH.\n* Participants who were a patient of the SJCRH Cancer Predisposition Clinic for at least 3 years before graduating from SJCRH\n* Participants who require cancer\u002Ftumor surveillance within 1 year after graduation from SJCRH. Required cancer\u002Ftumor surveillance in adulthood is defined as having a CPS with expert guidelines recommending cancer\u002Ftumor surveillance in adulthood\n* Participants fluent in English.\n\nExclusion Criteria:\n\n* Participants who are not their own legal medical decision-maker.",{"count":306,"type":18},56,"This observational study evaluates whether adolescents and young adults (AYAs) with a cancer predisposition syndrome (CPS) establish and maintain adult health care and continue CPS-specific cancer surveillance after graduating from pediatric care at St. Jude Children's Research Hospital (SJCRH). Participants will complete a Readiness Assessment and periodic surveys over 8 years post-graduation.\n\nPrimary Objectives\n\n* To evaluate whether adolescents and young adults (AYAs) with a cancer predisposition syndrome (CPS) report they have established care with adult health care providers and pursue CPS-specific cancer surveillance within 1-year post-graduation from SJCRH.\n* To evaluate whether AYAs with CPS report they maintain care with adult health care providers and continue CPS-specific cancer surveillance 3 years post-graduation from SJCRH.\n\nExploratory Objectives:\n\n* To evaluate whether AYAs with CPS report they continue to maintain care with adult health care providers and complete CPS-specific cancer surveillance longitudinally 5 years and 8 years post-graduation from St. Jude Children's Research Hospital (SJCRH).\n* To examine clinical correlates of establishing care with adult providers and initiating CPS-specific cancer surveillance post-graduation from SJCRH.\n* To identify the tumors diagnosed in AYAs with CPS after they graduate from SJCRH and determine how these tumors were identified (i.e., through specific surveillance tests or based on symptoms).\n* To identify barriers and facilitators AYAs face when establishing and maintaining adult health care and pursuing CPS-specific cancer surveillance.",[309],"Genetic Predisposition",[311,312,313,314],"Genetic cancer risk","Cancer predisposition","Health care transition","Adolescent and young adult oncology",{"date":294,"type":35},{"date":292,"type":35},{"date":318,"type":18},"2037-11",{"name":41,"class":42},{"id":321,"slug":4,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},"100560616","NCT06579469","Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy","Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)","Inclusion Criteria:\n\n* Participants must have received an initial systemically-administered CAR T cell infusion within the last 1-3 months (+\u002F- 14 days).\n\n  * Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT.\n* Age ≤ 30 years at CAR T cell infusion.\n\nExclusion Criteria:\n\n* Active malignancy other than the disease under study.\n* Planned consolidative HSCT within 3 months post CAR T cell infusion.\n* Received or planned additional disease directed therapy post CAR T cell infusion.\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.","30 Years",{"count":96,"type":18},"This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and\u002For have damage to the nervous system.",[330,331,332],"B-ALL","Hematologic Malignancy","Solid Tumor",[334,335],"CAR T cell infusion","Late Effects",{"date":294,"type":35},{"date":338,"type":35},"2026-01-20",{"date":340,"type":18},"2029-03",{"name":41,"class":42},6,{"id":344,"slug":4,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":15,"minAge":284,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":51,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":43},"100607635","NCT07191119","Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia","Feasibility and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Survivor of Acute Lymphoblastic Leukemia (ALL)\n* Enrolled on SJLIFE\n* Participant was less than 21 years of age at time of diagnosis.\n* Age 20-50 years at the time of enrollment\n* Insomnia Severity Index \\>=8 (Proxy \\>=8) confirmed prior to enrollment\n* Access to home Wi-Fi and Smartphone\n* Participant is able to speak and understand the English language\n* Participant is able and willing to give consent\n\nExclusion Criteria:\n\n* Unable to understand the details and requirements of the study (at the discretion of the PI)\n* Female participants who are pregnant or planning to become pregnant\n* Presence of implanted electrical medical devices (i.e. pacemaker)\n* Currently taking medication intended to treat neurocognitive impairment (i.e. stimulants) or medications prescribed for seizure management\n* History of skin irritation or other issues during stimulation of inner ear\n* Currently utilizing a technological intervention for a sleep disorder (e.g. CPAP)\n* Medications and behavioral practices (white noise, night-time yoga, etc) are acceptable as long as the insomnia is persistent.\n* History of a contraindicated health condition including:\n* Syncope (CTCAE \\>2)\n* Cardiac dysrhythmia (CTCAE \\>2)\n* Vascular Disease (CTCAE \\>2)\n* Coronary Artery Disease (CTCAE \\>2)\n* Active contraindicated heath condition including:\n* Cranial Nerve Disorder (CTCAE \\>2)\n* Neuropathy (Cranial Nerves) (CTCAE \\>2)\n* Neuralgia (Cranial Nerves) (CTCAE \\>2)\n* Overt Cerebrovascular Accident (CTCAE \\>2)\n* Seizures (Any in most recent 1 year\n* Currently enrolled or participating in any other neurostimulation or neuromodulation ancillary research studies","50 Years",{"count":351,"type":18},40,[53],"This pilot study will assess the usefulness and potential effectiveness of using transcutaneous auricular vagus nerve stimulation (tVNS) for treating insomnia in adult survivors of childhood acute lymphoblastic leukemia (ALL). Participants will be randomized to receive either active (verum) or inactive (sham) nightly stimulation using a non-invasive earbud device over two time periods: 2 weeks and 8 weeks. The study will assess adherence to the intervention and estimate its effects on sleep quality, stress, and neurocognitive function.\n\nPrimary Objective:\n\nAim 1: To determine a) short-term and b) long-term feasibility of tVNS in terms of participation in ALL Survivors with moderate to severe insomnia.\n\nAim 2: To estimate the effect size of tVNS on sleep quality, stress, and neurocognitive outcomes in ALL survivors with insomnia.\n\nExploratory Objectives\n\nAim 1: To investigate the onset of tVNS effect via actigraphy measures over the intervention epoch.\n\nAim 2: To estimate the effect size of genetic variants on sleep quality within verum tVNS.",[355,356,357],"Survivor of Childhood Cancer","Insomnia","Acute Lymphoblastic Leukemia (ALL)","2026-06-15",{"date":360,"type":35},"2026-06-17",{"date":362,"type":35},"2026-03-31",{"date":364,"type":18},"2029-12",{"name":41,"class":42},{"id":367,"slug":4,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":15,"minAge":372,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":51,"phases":376,"briefSummary":377,"conditions":378,"keywords":381,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":43},"100605292","NCT07160621","Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Cancer: A Randomized Clinical Trial","ADAPTED2","Inclusion Criteria:\n\n* Adolescent Participants\n\n  * 10-17-year-old survivors of childhood cancer or those who received cancer directed therapies (e.g., Langerhan's Histiocytosis)\n  * At least one-year post treatment completion\n  * Pain present for 3 months or longer\n  * Pain interfering with at least one area of daily functioning\n* Parent\u002FCaregiver Participants\n\n  * ≥ 18 years of age\n  * Legally authorized to provide informed consent for the adolescent participant\n\nExclusion Criteria:\n\n* Adolescent Participants\n\n  * Serious comorbid psychiatric condition\n  * Current substance abuse as determined by the Substance Use Screening Questionnaire\n  * History of development delay or significant cognitive impairment\n\n    * Note: A participant who completed the feasibility study (ADAPTED) cannot participate in the subsequent clinical trial (ADAPTED2)\n* Parent\u002FCaregiver Participants\n\n  * Not fluent in English or Spanish\n  * Unable to provide consent for own participation or for the participation of the adolescent participant","10 Years","17 Years",{"count":375,"type":18},228,[53],"The purpose of the study is to determine if an adapted mobile cognitive behavioral therapy (CBT) app (WebMAP Onc) is more effective than standard pain education in reducing chronic pain and improving daily functioning in adolescent survivors of pediatric cancer.\n\nThis randomized study led by St. Jude Children's Research Hospital will involve 228 participants (114 adolescent survivors and 114 caregivers) across four U.S. hospitals. Outcomes include pain reduction, improved function, and the role of social determinants of health. Assessments occur at baseline, post-treatment, and 3-month follow-up.",[379,380],"Childhood Cancer Survivor","Chronic Pain",[382,383],"Adult Caregiver","Adolescent Survivor",{"date":360,"type":35},{"date":386,"type":35},"2025-09-05",{"date":388,"type":18},"2029-01",{"name":41,"class":42},{"id":391,"slug":4,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":15,"minAge":396,"maxAge":373,"enrollmentInfo":397,"targetDuration":4,"studyType":51,"phases":399,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":405,"leadSponsor":406,"locationsCount":4},"100577383","NCT06797583","Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease","PHOTOSCAN","Inclusion Criteria:\n\n* Patient diagnosed with sickle cell disease of any genotype\n* Enrolled in the Sickle Cell Clinical Research and Intervention Program (SCCRIP)\n* Between the ages of 8 to 17 years\n* Primary language is English\n* Participant and Parent\u002FLegal Guardian is willing to participate and provide consent\u002Fassent according to institutional guidelines\n\nExclusion Criteria:\n\n* History of an abnormal transcranial doppler screening\n* History of a documented silent cerebral infarct\n* History of documented central nervous system injury, including a traumatic brain injury, Moya Moya disease, or overt stroke\n* Participant received transfusion treatment within the past three months.","8 Years",{"count":398,"type":18},60,[53],"Participants are being asked to take part in this clinical trial, a type of research study, because investigators want to learn more about oxygen usage in the brain. Patients diagnosed with sickle cell disease are at risk for difficulties with thinking and academic skills. The brain requires a consistent supply of oxygen for normal function, but this supply is reduced among patients with sickle cell disease. The development of new treatments to improve cerebrovascular functioning is needed to limit these difficulties. Transcranial photobiomodulation (i.e., light stimulation to the brain) has the potential to improve cerebrovascular and neurocognitive functioning among patients with sickle cell disease.Participants will be selected randomly (like the flip of a coin) to receive either active light therapy or placebo (no active light treatment).\n\nPrimary Objectives\n\n* Measure the participation rate in a study of transcranial photobiomodulation to improve cognitive functioning in a sample of children with sickle cell disease (ages 8- 17 years).\n* Assess self- and caregiver-reported ratings of feasibility and acceptability.\n* Evaluate the frequency and nature of side effects associated with transcranial photobiomodulation.\n\nSecondary Objectives\n\n* To assess the change in cognitive performance associated with transcranial photobiomodulation compared to a sham control condition.\n* To measure changes in cerebrovascular oxygenation (oxygenated and deoxygenated hemoglobin) following transcranial photobiomodulation compared to a sham control condition.",[215],[215],{"date":360,"type":35},{"date":110,"type":18},{"date":364,"type":18},{"name":41,"class":42},{"id":408,"slug":4,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":15,"minAge":396,"maxAge":412,"enrollmentInfo":413,"targetDuration":4,"studyType":51,"phases":415,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":43},"100512022","NCT05947045","Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors","Inclusion Criteria:\n\n* Initiating radiotherapy for a BT\n* Between 8-22 years of age at the time of enrollment\n* English or Spanish as the primary language\n* Research participant and one parent willing to participate and provide consent\u002Fassent according to institutional guidelines\n* Participant willing to take part in required aspects of Cogmed training\n\nExclusion Criteria:\n\n* Significant impairment in global intellectual functioning (estimated or full scale IQ \\\u003C 70 based on standardized testing routinely conducted on primary treatment protocols or as part of the New Oncology Program in Psychology \\[NOPP\\])\n* History of significant neurological disease preceding BT diagnosis including stroke or head injury with loss of consciousness\n* Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures\u002Fphotosensitive epilepsy, inadequate balance to sit or stand unassisted to complete cognitive training)\n* Psychiatric condition that would preclude or take precedence over study participation (e.g. active psychosis, suicidal ideation)\n* Need for general anesthesia during radiation therapy (note: can participate if only sedated for simulation\u002Fplanning but not daily treatment)","22 Years",{"count":414,"type":18},45,[53],"The objective of this study is to estimate the feasibility and acceptability of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors. To achieve this goal, the investigators plan to study children undergoing radiotherapy for brain tumors randomly assigned to cognitive training administered via an iPad or virtual reality. Both groups will also participate in cognitive testing and exams using functional near infrared spectroscopy (fNIRS) pre- and post-intervention. The questions to be investigated are:\n\n1. Will cognitive training via virtual reality be feasible and acceptable for children undergoing radiotherapy for brain tumors as indicated by participation rates, adherence and frequency of side effects?\n2. Will cognitive training via virtual reality provide neurocognitive benefits?\n3. Will there be predictable changes in brain activity as measured by neuroimaging?\n\nFindings from this study will be used to develop a larger, definitive trial with direct potential to improve cognitive outcomes for children treated for cancer using a safe and effective alternative to desktop- or laptop-based computerized cognitive interventions with great promise for improving quality of life.",[418],"Brain Tumor",[420,421,422,423,424],"Radiotherapy","Brain tumor","Cognitive training","Virtual Reality","Working memory",{"date":360,"type":35},{"date":427,"type":35},"2023-06-22",{"date":429,"type":18},"2027-03",{"name":41,"class":42},{"id":432,"slug":4,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":43},"100494056","NCT05713214","Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products","Inclusion Criteria:\n\n* Receipt of a genetically modified cell product on a St. Jude investigator-initiated study within the prior 15 years.\n\nExclusion Criteria:\n\n* Inability or unwillingness of research participant and\u002For legal guardian\u002F representative to give written informed consent.",{"count":437,"type":18},500,"Human gene therapy products are designed to achieve therapeutic effect through genetic modifications of human cells using retroviral or lentiviral vectors, resulting in permanent or long-acting changes in the human body. With this genetic modification comes risk of undesirable adverse events. Due to this risk, the Food and Drug Administration (FDA) and the Center for Biologics Evaluation and research (CBER) require long-term follow-up (15 years) of participants that receive investigational gene therapy products that meet defined criteria. This protocol will provide a mechanism by which to appropriately monitor participants that have received a genetically modified cellular product on a St. Jude initiated study.",[440,441],"Relapsed Hematologic Malignancy","Refractory Hematologic Malignancy",{"date":360,"type":35},{"date":444,"type":35},"2023-02-08",{"date":446,"type":18},"2052-12-01",{"name":41,"class":42},{"id":449,"slug":4,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":412,"enrollmentInfo":453,"targetDuration":4,"studyType":51,"phases":454,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":43},"100490283","NCT05664113","Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).","Inclusion Criteria:\n\n* Age \\\u003C 22 years old.\n* Received an allogeneic HCT greater than or equal to 30 days prior to enrollment\n* Diagnosed with one of the following conditions:\n\n  1. Steroid-resistant gut a GvHD (defined as GI symptoms that do not improve within 5 days after initial steroid therapy, \\>\u002F= 1mg\u002Fkg of prednisolone) OR\n  2. Steroid-dependent gut a GvHD (defined as the presence of a response to methylprednisolone 2 mg\u002Fkg\u002Fday but relapsing when an attempt was made to taper steroid treatment).\n\n     OR\n  3. Current or prolonged GI dysfunction following HCT, defined as having diarrhea or loose stools \\>\u002F= 4 weeks with at least one of the following:\n\n     1. Requiring NG or G-tube feeds\n     2. Requiring TPN or IVF for more than 4 weeks\n     3. Diagnosis of gastroparesis by GI specialist documented in the medical record\n* Willing and able to provide informed assent\u002Fconsent\n\nExclusion Criteria:\n\n* Patient is at risk for aspiration pneumonia\n* History of anaphylactic allergy to foods that are not excluded from the stool donor diet\n* Female participant who is pregnant or nursing\n* History of previous FMT\n* Intra-abdominal surgery within 4 weeks of enrollment\n* At increased risk for peritonitis: presence of intra-abdominal devices (G-or GJ-tubes are acceptable), receiving peritoneal dialysis, or ascites\n* Concurrent abdominal radiation therapy\n* Any acute or chronic illness\u002Fcondition as well as medication that in the opinion of the investigator puts the subject at greater risk from FMT or may confound the study results.",{"count":187,"type":18},[455],"PHASE1","The study participant is being asked to take part in this clinical trial, a type of research study, because the participant has Gastrointestinal (GI) symptoms following a Hematopoietic Cell Transplant (HCT).\n\nPrimary Objective\n\n* To determine the safety and feasibility of FMT for treating a GvHD of the gut following HCT.\n* To determine the safety and feasibility of FMT for treating HCT induced gut dysfunction.\n\nSecondary Objectives\n\n* To assess the potential efficacy of FMT for treating a GvHD of the gut following HCT.\n* To assess the potential efficacy of FMT for treating HCT induced gut dysfunction.",[458],"Gastro-Intestinal Disorder",{"date":360,"type":35},{"date":461,"type":35},"2025-07-07",{"date":463,"type":18},"2028-12-31",{"name":41,"class":42},{"id":466,"slug":4,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":15,"minAge":471,"maxAge":472,"enrollmentInfo":473,"targetDuration":4,"studyType":51,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":491},"100367552","NCT04065776","Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma","A Phase II Study of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma","Inclusion Criteria:\n\n* Patients must have a diagnosis of pilocytic astrocytoma, pilomyxoid astrocytoma, pleomorphic xanthoastrocytoma, ganglioglioma, optic pathway glioma, diffuse astrocytoma, low-grade neuroepithelial tumor, low-grade glioneuronal tumor or LGG, or not otherwise specified (NOS).\n* Patient with eligible diagnosis other than optic pathway glioma or tumors of the brainstem\u002Fmidbrain\u002Ftectum has histologic verification of disease at diagnosis or recurrence OR\n* Patient with optic pathway glioma or tumors of the brainstem\u002Fmidbrain\u002Ftectum has radiologic verification of disease at diagnosis or recurrence\n* A repeat biopsy was done because the recurrent tumor was enhancing but did not originally enhance because there was a high index of suspicion regarding high-grade transformation\n* Tumor must be located in the suprasellar region or midline structures. Midline structures include, but are not limited to, the thalamus, basal ganglia, internal capsule, midbrain, tectum, third ventricle, fourth ventricle, cerebellum, pons, and medulla. Tumors may involve the optic pathway. For questions about tumor locations that are not specified on this list, please contact the Study PI.\n* Patients must be at least 6 years but less than 22 years of age at the time of enrollment.\n* Patients must have a performance status greater or equal to 70 (use Karnofsky scale for patients aged 16 years and older and Lansky scale for patients aged less than 16 years).\n* Patients may not receive concurrent chemotherapy or targeted therapy, including but not limited to BRAF-inhibitors and MEK-inhibitors.\n* All patients must be able to undergo contrast-enhanced brain MRI.\n* All patients must have adequate organ function as described below.\n\n  * Peripheral absolute neutrophil count (ANC) ≥ 1000\u002FµL\n  * Platelet count ≥ 10,000\u002FµL (transfusion independent)\n  * Patients with seizures may be enrolled if well controlled on anticonvulsants\n\nExclusion Criteria:\n\n* Patients may not have received prior CNS radiation.\n* Patients with gross total resection and no measurable disease via MRI are not eligible. Patients must have measurable disease of at least 1 cm via MRI.\n* Patients with evidence of metastatic disease are not eligible.\n* Patients with WHO grade II midline tumors that harbor the H3K27M mutation, IDH-mutant gliomas, grade II ependymomas and subependymomas, pituicytomas, spindle cell oncocytomas, or granular cell tumors of the sellar region are not eligible.\n* Patients with tumors that directly invade the hippocampus or with gross tumor volumes that extend into the hippocampus are not eligible.\n* Patients with tumors in the spine or cervicomedullary junction.\n* Females of child-bearing potential cannot be pregnant or breast feeding. Female participants \\> 10 years of age or post menarche must have a negative serum or urine pregnancy test before enrollment. Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.\n* Patients who are status post resection of bilateral hippocampi. Patients who are status post resection of one hippocampus will be eligible for the study and the hippocampal dose constraints will be applied to the intact hippocampus.","6 Years","21 Years",{"count":474,"type":18},74,[53],"Low-grade gliomas (LGGs) are the most common brain tumors in children, and a subset of these tumors are treated definitively with focal radiation therapy (RT). These patients often survive for many years after receiving RT and experience late deficits in memory. Verbal recall is an important measure of memory and is associated with other important functional outcomes, such as problem-solving, independence of every-day functioning, and quality of life. Decline in memory, as measured by verbal recall, is associated with RT dose to the hippocampi. Therefore, this phase II study investigates the feasibility of reducing RT doses to the hippocampi (i.e., hippocampal avoidance \\[HA\\]) by using proton therapy for midline or suprasellar LGGs.\n\nPrimary Objective:\n\n* To determine the feasibility of HA with proton therapy in suprasellar or midline LGGs. Feasibility will be established if 70% of plans meet the first or second dose constraints shown below.\n\n  1. First priority RT dose constraints for bilateral hippocampi: volume receiving 40 CGE (V40CGE) ≤ 25%, dose to 100% of Hippocampus (D100%) ≤ 5CGE.\n  2. Second priority RT dose constraints for bilateral hippocampi: V40CGE ≤ 35%, D100% ≤ 10 CGE.\n\n     Secondary Objectives:\n* To estimate the 3-year event-free-survival (EFS) for LGGs treated with HA.\n* To estimate the change in California Verbal Learning Test short-term delay (CVLT-SD) from baseline to 3 years and from baseline to 5 years\n* To compare CVLT-SD and Cogstate neurocognitive scores in patients with proton therapy plans that: (1) meet first priority RT dose constraints, (2) meet second priority RT dose constraints but not first priority RT dose constraints, and (3) that did not meet either first or second RT priority dose constraints\n\nExploratory Objectives:\n\n* To describe the change in overall cognitive performance from baseline to 3 years and from baseline to 5 years with an age appropriate battery, including gold standard measures shown in the published studies to be sensitive to attention, memory processing speed and executive function that will afford comparison to historical controls.\n* To characterize longitudinal changes in connection strength within brain networks in the first 3 years after proton therapy and to investigate associations between these changes and neurocognitive performance with focus on the hippocampi.\n* To correlate the distribution and change in L-methyl-11C-methionine positron emission tomography (MET-PET) uptake to tumor progression and from baseline to 3 years and to investigate whether cases of pseudoprogression exhibit a differential pattern of uptake and distribution compared to cases of true progression after controlling for histology.\n* To investigate the effect of BRAF alteration, tumor histology and tumor location on PFS and OS in a prospective cohort of patients treated in a homogenous manner.\n* To investigate whether the methylation profiles of LGGs differ by tumor location (thalamic\u002Fmidbrain vs. hypothalamic\u002Foptic pathway vs. others) and histologies (pilocytic astrocytoma vs. diffuse astrocytoma vs. others), which, in conjunction with specific genetic alterations, may stratify patients into different subgroups and highlight different therapeutic targets.\n* To record longitudinal measures of circulating tumor DNA (ctDNA) in plasma and correlate these measures with radiographic evidence of disease progression.\n* To bank formalin-fixed, paraffin-embedded (FFPE)\u002Ffrozen tumors and whole blood from subjects for subsequent biology studies not currently defined in this protocol.\n* To quantify and characterize tumor infiltrating lymphocytes (TILs) and to characterize the epigenetics of T cells and the T cell receptor repertoire within the tumor microenvironment.\n* To estimate the cumulative incidence of endocrine deficiencies, vision loss, hearing loss and vasculopathy after proton therapy and compare these data to those after photon therapy.",[478,479,480,481,482,483,484],"Glioma","Pilocytic Astrocytoma","Pilomyxoid Astrocytoma","Pleomorphic Xanthoastrocytoma","Ganglioglioma","Optic Pathway Glioma","Diffuse Astrocytoma",{"date":360,"type":35},{"date":487,"type":35},"2019-08-28",{"date":489,"type":18},"2028-07",{"name":41,"class":42},2,{"id":493,"slug":4,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":500,"conditions":501,"keywords":546,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":43},"100289631","NCT03050268","Familial Investigations of Childhood Cancer Predisposition","SJFAMILY","NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown below, you may enroll regardless of the results of your clinical genetic testing.\n\nDEFINITION OF FAMILIAR CANCER FOR THIS PROTOCOL:\n\nIn this protocol, the definition of \"Familial Cancer\" is met if any of the following is present:\n\n* An individual with a history of cancer diagnosed under 26 years of age who has at least one first, second or third degree relative with a history of cancer diagnosed under 51 years of age; OR\n* An individual who has been diagnosed with more than one cancer, at least one of which was diagnosed under 26 years of age; OR\n* An individual with a clinical or molecular diagnosis of a known cancer predisposition syndrome; OR\n* An individual with a congenital cancer diagnosed before 6 months of age; OR\n* An individual with a rare pediatric cancer or tumor diagnosed before 26 years of age\n\nº Excluding human papilloma virus-associated cervical cancer and non-melanoma skin cancer occurring in adults.\n\nINCLUSION CRITERIA:\n\n* An individual who meets this protocol's definition of \"Familial Cancer,\" as above.\n* Biologic relatives of an individual meeting this protocol's definition of \"Familial Cancer,\" who are either affected or unaffected by cancer.\n\nEXCLUSION CRITERIA:\n\n* An inability or unwillingness of the research participant or his\u002Fher legally authorized representative (LAR) to provide written informed consent.\n* The participant has received allogeneic bone marrow transplantation and has NO pre-transplant germline (cancer-unaffected) DNA available AND is unwilling to provide a skin sample.",{"count":499,"type":18},1500,"NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown in the Eligibility Section, you may enroll regardless of the results of your clinical genetic testing.\n\nWhile it is well recognized that hereditary factors contribute to the development of a subset of human cancers, the cause for many cancers remains unknown. The application of next generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary cancer predisposition. Currently, more than 100 cancer predisposing genes have been identified, and it is now estimated that approximately 10% of all cancer patients have an underlying genetic predisposition.\n\nThe purpose of this protocol is to identify novel cancer predisposing genes and\u002For genetic variants. For this study, the investigators will establish a Data Registry linked to a Repository of biological samples. Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer. The investigators will use NGS approaches to find changes in genes that may be important in the development of familial cancer. The information gained from this study may provide new and better ways to diagnose and care for people with hereditary cancer.\n\nPRIMARY OBJECTIVE:\n\n* Establish a registry of families with clustering of cancer in which clinical data are linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues from the proband and other family members.\n\nSECONDARY OBJECTIVE:\n\n* Identify novel cancer predisposing genes and\u002For genetic variants in families with clustering of cancer for which the underlying genetic basis is unknown.",[502,503,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,104,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,101,543,544,545],"Acute Leukemia","Adenomatous Polyposis","Adrenocortical Carcinoma","AML","BAP1 Tumor Predisposition Syndrome","Carney Complex","Choroid Plexus Carcinoma","Constitutional Mismatch Repair Deficiency Syndrome","Diamond-Blackfan Anemia","DICER1 Syndrome","Dyskeratosis Congenita","Emberger Syndrome","Familial Acute Myeloid Leukemia","Familial Adenomatous Polyposis","Fanconi Anemia","Familial Cancer","Familial Wilms Tumor","Familial Neuroblastoma","GIST","Hereditary Breast and Ovarian Cancer","Hereditary Paraganglioma-Pheochromocytoma Syndrome","Juvenile Polyposis","Li-Fraumeni Syndrome","Lynch Syndrome","MDS","Melanoma Syndrome","Multiple Endocrine Neoplasia Type 1","Multiple Endocrine Neoplasia Type 2","Neuroblastoma","Neurofibromatosis Type 1","Neurofibromatosis Type II","Nevoid Basal Cell Carcinoma Syndrome","Non Hodgkin Lymphoma","Noonan Syndrome and Other Rasopathy","Overgrowth Syndromes","Pancreatic Cancer","Peutz-Jeghers Syndrome","Pheochromocytoma\u002FParaganglioma","PTEN Hamartoma Tumor Syndrome","Retinoblastoma","Rhabdoid Tumor Predisposition Syndrome","Rothmund-Thomson Syndrome","Tuberous Sclerosis","Von Hippel-Lindau Disease",[547,548,549,550,551,552,553,554,555],"Familial cancer","Genetic predisposition","Heritable disease","Cancer risk","Genome analysis","Genetic modifiers","Next generation sequencing (NGS)","Genetic counseling","DNA",{"date":360,"type":35},{"date":558,"type":35},"2017-04-06",{"date":560,"type":18},"2037-03-31",{"name":41,"class":42},{"id":563,"slug":4,"hasResults":11,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":43},"100249818","NCT02530658","Next Generation Sequencing of Normal Tissues Prospectively in Pediatric Oncology Patients","Genomes for Kids (G4K)","Inclusion Criteria:\n\n* St. Jude patients prospectively identified at the time of study activation with a diagnosed solid or liquid tumor (benign or malignant).\n* Adequate tissue must be available (e.g. sufficient germline and\u002For tumor tissue, from which \\>1 µg DNA and \\>0.1 µg RNA must be isolated). Patients who have no tumor tissue available may enroll using only germline sample.\n\nExclusion Criteria:\n\n* Past history of hematopoietic stem cell transplantation (or other condition that would result in hematopoietic cell DNA failing to match host tissue DNA).\n* Tumor or germline tissue not meeting the criteria listed above.\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n* Participants who are unable to read, write or converse fluently in English or Spanish will be excluded from Prespecified Objectives 3 and 4.",{"count":569,"type":18},2500,"The development of next generation sequencing (NGS) techniques, including whole genome (WGS), exome (WES) and RNA sequencing has revolutionized the ability of investigators to query the molecular mechanisms underlying tumor formation. Through the Pediatric Cancer Genome Project (PCGP), investigators at St. Jude Children's Research Hospital (SJCRH) have successfully used NGS approaches to evaluate more than 1,000 pediatric cancers ranging from hematologic malignancies to central nervous system (CNS) and non-CNS solid tumors. From these and related studies, it has become clear that genomic approaches can accurately classify tumors into distinct pathologic and prognostic subtypes and detect alterations in cellular pathways that may serve as novel therapeutic targets. Collectively, these studies suggest that by characterizing the genomic make-up of individual tumors, investigators will be able to develop personalized and potentially more effective cancer treatments and\u002For preventive measures.\n\nThis protocol was initially enacted to usher NGS approaches into routine clinical care. During the initial phase of the G4K protocol, 310 participants were recruited and enrolled onto the study. Tumor and\u002For germline sequencing was completed on all 310 patients, with 253 somatic reports generated (representing 96% of the 263 participants for whom tumor tissue was available and analyzed) and 301 germline reports generated (100% of the 301 participants who agreed to the receipt of germline results). Analyses of the study data are ongoing with plans to prepare initial manuscripts within the next several months. Due to the successful initial execution of the G4K protocol, clinical genomic sequencing of tumor and germline samples is now offered as part of standard clinical care for pediatric oncology patients at St. Jude.\n\nThe G4K protocol has now been revised. With the revision, the study team will record, store and analyze germline and tumor genomic information. Through the collection of these data, we will examine how germline mutations in 150 cancer predisposition genes influence clinical presentation, tumor histology, tumor genomic findings, response to therapy and long-term outcomes. The overall goals of this research are to further define the prevalence, spectrum and heritability of germline variants in these genes and to decipher how germline mutations influence the phenotypes of an expanding array of cancer predisposition syndromes. These studies allow us to provide more accurate genetic counseling and management strategies to future children harboring mutations in these genes.\n\nThis remains a non-therapeutic study. Investigators anticipate a sample size of approximately 2500 patients who will be recruited over the next 7 years.",[572],"Solid, Liquid, Central Nervous System Tumors",[309,574,575,576,577,578,555,579,580,581,582],"Pediatric","Genomic Analysis","Heritable Disease","Cancer Risk","Genetic Counseling","Clinical Genomics","Clinical Decision-Making","Treatment Planning","Germline",{"date":360,"type":35},{"date":585,"type":35},"2015-08-28",{"date":587,"type":18},"2038-12-31",{"name":41,"class":42},{"id":590,"slug":4,"hasResults":11,"nctId":591,"briefTitle":592,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":49,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":596,"conditions":597,"keywords":599,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":609},"100142079","NCT01120353","Childhood Cancer Survivor Study","Inclusion Criteria:\n\nInitial Cohort:\n\n* Five-year survival following diagnosis of leukemia, lymphoma, CNS tumor, bone tumor, Wilms tumor, neuroblastoma, or soft tissue sarcoma before age 21 years between January 1, 1970 and December 31, 1986 at one of participating centers.\n\nExpanded cohort:\n\n* Five-year survival following diagnosis of leukemia, lymphoma, CNS tumor, bone tumor, kidney tumor, neuroblastoma, or rhabdomyosarcoma before age 21 years between January 1, 1987 and December 31, 1999 at one of participating centers.\n* English- or Spanish-speaking and living in the U.S. or Canada at the time of diagnosis.\n\nExclusion Criteria:\n\n* Diagnosis of non-malignant tumors (i.e., Langerhans cell histiocytosis, meningioma, craniopharyngioma, etc.) treated with radiation and\u002For chemotherapy.\n* Non-English speaking or residence outside the US or Canada.\n\nSibling Controls:\n\n* For comparison purposes, a group of sibling controls will be identified to represent a stratified random sample based on the distribution of survivors with regard to cancer diagnosis, age, sex, race, and geographic location.",{"count":595,"type":18},50000,"The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of cancer and its associated therapies. A retrospective cohort study will be conducted through a multi-institutional collaboration, which will involve the identification and active follow-up of a cohort of approximately 50,000 survivors of cancer, diagnosed before 21 years of age, between 1970 and 1999 and 10,000 sibling controls. This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and\u002For surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes.",[598],"Cancer",[600,601,602],"Childhood cancer","Young Children","Adults",{"date":360,"type":35},{"date":605,"type":35},"1995-01-05",{"date":607,"type":18},"2026-11",{"name":41,"class":42},31,""]