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Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy

StatusRecruiting
PhasePhase 2
Started2024-08-30
View on ClinicalTrials.gov ↗

Amendment history

2026-09-08
minor
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
2026-06-04
minor
Study Status, Study Design, Contacts/Locations v6
Enrollment target147→127
Study sitescontacts updated at 1 of 1 site
2025-09-11
minor
Study Status v5
Re-verified, no change to tracked fields
2024-09-11
minor
Study Identification, Study Status, Contacts/Locations v4
Start dateestimated 2024-09→confirmed 2024-08-30
Study sitescontacts updated at 1 of 1 site
2024-08-12
minor
Study Status v3
Start date2024-07→2024-09
Show 2 earlier versions
2024-06-11
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2024-05→2024-07
Study sites0→1
Eligibility criteria+302 characters
[...] ndidate for radical cystectomy Be able to undergo pelvic MRI. Minimum standards for MRI imaging will include the following: MRI of the pelvis on 1.5T or higher strength magnet. T2 weighted imaging in multiple planes. T1 weighted imaging pre and post contrast administration (unless contrast is contraindicated by allergy or renal insufficiency) Cystoscopic evaluation completed by urologist within 120 day [...] RC or RC) Written informed consent obtained from the subject or the subject's legal representative and the ability for the subject to comply with all the stud [...] andidate for radical cystectomy Unabl [...]
2024-04-16
minor
Study Status v1
Start date2024-03→2024-05
2023-12-14
minor
Original filing
Currently, the standard of care for female patients undergoing radical cystectomy includes the removal of the bladder, pelvic lymph nodes, anterior vagina, uterus, fallopian tubes and ovaries. Removal of female ancillary organs, both in pre and post-menopausal stages is associated with reduction in various quality of life metrics, including sexual health, cognitive decline and depression. Furthermore, removal of ovaries has been associated with increased cardiovascular events, metabolic acidosis, osteoporosis and bone fractures. In premenopausal women, the removal of the ovaries is associated with increased all-cause mortality. From an oncologic standpoint, multi institutional retrospective reviews have demonstrated certain pre-operative radiographic and cystoscopic risk factors that are associated with bladder cancer involvement of female reproductive organs. The absence of these unfavorable risk factors may provide an opportunity to spare women from undergoing unnecessary reproductive organ removal during RC. In doing so, this may eliminate the associated sequelae of removing these additional organs while also providing acceptable oncologic care. The investigators thus propose a decision tool to stratify women undergoing radical cystectomy as favorable and unfavorable for reproductive organ sparing radical cystectomy. This decision tool classification will be used to decide which patients will undergo reproductive organ sparing radical cystectomy versus radical cystectomy in this study.
Trial Details
NCT Number NCT06184516
Lead Sponsor University of Florida
Conditions Urothelial Carcinoma Bladder
Enrollment 127 participants
Start Date 2024-08-30
Primary Completion 2027-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-09