[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100380605":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":59,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"1\u002F Cohort 1",null,"Bladder Cancer Patients",[13,14],"Device: modified resectoscope","Procedure: TURBT",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DEVICE","modified resectoscope","The modified resectoscope will be used post cystectomy (En-bloc TURBT) to resect areas of the tumor from the cystectomy specimen. These resected tumors will be sent for histopathology to assess the size of resection, depth of resection, and ability to ascertain tumor orientation and compared to the remainder of the cystectomy specimens to see if the modified resectoscope can provide improved pathologic standards for the TURBT procedure.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"PROCEDURE","TURBT","All patients will receive routine surgical transurethral resection of bladder tumors (TURBT).",[9],[27],{"name":28,"affiliation":29,"role":30},"Raju R Chelluri, M.D.","National Cancer Institute (NCI)","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"NCI Medical Oncology Referral Office","CONTACT","(240) 760-6050","ncimo_referrals@nih.gov",{"name":28,"role":34,"phone":38,"phoneExt":10,"email":39},"(240) 858-3700","raju.chelluri@nih.gov",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-77.10026,38.98067,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":58,"phoneExt":10,"email":10},"For more information at the NIH Clinical Center contact National Cancer Institute Referral Office","888-624-1937",{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100380605","en-bloc-transurethral-resection-of-bladder-tumor-en-bloc-turbt-specimens-using-a-redesigned-surgical-resectoscope-device-100380605",false,"NCT04235764","En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device","Ex-Vivo Trial of En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device","* INCLUSION CRITERIA:\n* Patients requiring surgical removal of the bladder at the NIH Clinical Center.\n\nNOTE: Reasons for need for surgical removal of bladder include cancer or benign condition for which a surgeon determined surgical removal of the bladder is recommended. Patient's with invasive bladder cancer requiring cystectomy are eligible for enrollment. Bladder cancer remains the most common reason for cystectomy. Patients with clinical advanced disease and having other treatments\u002For participating in other trials remain eligible for enrollment in this study.\n\n* Men and women\n* Age greater than or less than 18 years\n* Deemed clinically appropriate for the planned surgical procedure.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Subjects will be asked to co-enroll in 15-C-0087, \"Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens from Healthy Volunteers and Urothelial Cancer Patients.\" NOTE: Most participants are expected to already be enrolled in 15-C-0087 prior to entry in this study.\n\nEXCLUSION CRITERIA:\n\n\\- Cystectomy during pregnancy would subject the fetus to significant risk of miscarriage or premature labor. For this reason, pregnant women are ineligible for this study.","ALL","18 Years","120 Years",{"count":72,"type":73},25,"ESTIMATED","OBSERVATIONAL","Background:\n\nBladder cancer is the sixth most common cancer in the United States. The way that doctors remove tumors in bladder surgeries may leave some cancer . Also, many people have their tumors return or progress after surgery. Researchers want to test a modified device. It might tell doctors more about bladder tumors.\n\nObjective:\n\nTo see if using a modified standard device with bladder surgery can provide better information about tumors in bladder specimens.\n\nEligibility:\n\nPeople ages 18 and older who need to have their bladder removed at the NIH.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical and prior surgical history\n\nReview of existing MRI, x-ray, or CT scans\n\nReview of existing specimens and reports\n\nPregnancy test for women of childbearing age\n\nCT or MRI: Participants will lie in a machine. The machine will take pictures of their body.\n\nParticipants will have bladder surgery. This will occur in the same way as if they did not take part in this study. A member of the research team will cut the removed bladder using the modified device. This will most likely be done on a separate back table in the operating room. The bladder and samples after cutting will be sent out for review. The will occur just as it would if the participants were not in this study. The only difference is the way that the specimen is prepared for review.\n\nParticipants follow-up care will occur per standard of care. Or it will occur as part of any other study in which they might also be enrolled.\n\n...",[77],"Bladder Cancer",[23,79,80,81,82],"Transurethral Resection of Bladder Tumors","Cystectomy","Modified Resectoscope","Natural History","2026-06-17",{"date":85,"type":86},"2026-06-18","ACTUAL",{"date":88,"type":86},"2020-09-09",{"date":90,"type":73},"2027-09-30",{"name":29,"class":6},1]