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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06184516
Phase
PHASE2
Status
Recruiting
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Conditions

  • Urothelial Carcinoma Bladder

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Reproductive organ sparing radical cystectomy — PROCEDURE
    Participants on this arm will undergo a reproductive organ sparing radical cystectomy if they are classified as "favorable" based on the decision tool.
  • Radical cystectomy — PROCEDURE
    Participants on this arm will undergo a radical cystectomy if they are classified as "unfavorable" based on the decision tool.

Study Details

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.

Key Dates

Start date
Aug 30, 2024
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
127 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Reproductive organ sparing radical cystectomy
  • Active Comparator: Radical cystectomy

Primary Outcome Measure

Positive margin rate [ Time Frame: 120 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608
Nicole Davila Torres
[email protected]
352-273-6913
Tarik Benidir, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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