Actively Recruiting
Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy
Led by University of Florida · Updated on 2026-06-08
127
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Women undergoing radical cystectomy for bladder cancer typically have their bladder and several reproductive organs removed. This standard procedure can lead to reduced quality of life, affecting sexual health, cognitive function, and mental health. Removal of the ovaries, especially in premenopausal women, may also increase risks such as cardiovascular problems, bone issues, and overall mortality. Researchers are studying a decision tool to identify women who can safely avoid removal of reproductive organs during surgery, aiming to maintain quality of life while providing effective cancer treatment. Participants will be assigned to one of two surgical approaches based on the decision tool: reproductive organ sparing radical cystectomy for those classified as favorable, or standard radical cystectomy for those classified as unfavorable. The study uses pelvic MRI and cystoscopic evaluations to help classify patients. Both procedures involve removal of the bladder, but differ in whether reproductive organs like the uterus, ovaries, and fallopian tubes are also removed. During the study, participants will undergo pelvic imaging and cystoscopy before surgery to assess cancer involvement. Researchers will measure outcomes such as positive surgical margin rates within 120 days, sexual function and quality of life up to 15 months, and recurrence of cancer locally and at distant sites within 12 months. The study also assesses prediction accuracy for disease spread and pelvic organ involvement. Follow-up includes monitoring for cancer recurrence and quality of life effects for over a year after surgery.
CONDITIONS
Brief Title
Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Histologically confirmed diagnosis of urothelial carcinoma of the bladder, including variant histology
- Surgical candidate for radical cystectomy
- Ability to undergo pelvic MRI on a 1.5T or higher strength magnet with T2 weighted imaging in multiple planes and T1 weighted imaging pre and post contrast if not contraindicated
- Cystoscopic evaluation completed by a urologist within 120 days prior to surgery
- Staging imaging including pelvic MRI within 90 days prior to surgery, with repeat imaging after neoadjuvant therapy if given
- Written informed consent and ability to comply with study procedures
- Presence of at least one ancillary reproductive organ (anterior vagina, uterus, fallopian tubes, or ovaries)
- ECOG Performance Status of 0 to 2
You will not qualify if you...
- Presence of regional or distant metastatic disease
- Non-urothelial bladder cancer
- Not a surgical candidate for radical cystectomy
- Unable to undergo required pelvic MRI
- Women of childbearing potential unwilling or unable to use acceptable contraception during and for 12 weeks after intervention
- Other active malignancies that may affect recurrence rates
- Known germline mutations in DNA damage repair genes (BRCA1 or BRCA2)
- Prisoners or involuntarily incarcerated individuals
- Subjects compulsorily detained for psychiatric or physical illness
- Inability to comply with study or follow-up procedures
- Confirmed pregnancy or breastfeeding
- History of disease or condition contraindicating protocol therapy or affecting study results as judged by physician
- Receipt of live virus vaccine within 30 days prior to study intervention (except non-live COVID vaccines)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 120 days
Participants undergo either a reproductive organ sparing radical cystectomy or a radical cystectomy based on classification by the decision tool.
1 surgical procedure with follow-up assessments
Duration - Up to 15 months
Participants are monitored for sexual function, quality of life, local and distant recurrence, and incidence of adjacent pelvic organ involvement.
Periodic visits for assessments up to 15 months
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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