RecruitingPhase 2NCT06184516

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


Sponsor

University of Florida

Enrollment

147 participants

Start Date

Aug 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a decision-making tool to help doctors determine which women with bladder cancer can safely keep their reproductive organs (uterus and ovaries) during bladder removal surgery. Currently, these organs are often removed by default, but this may not always be necessary. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with bladder cancer confirmed by biopsy - Your doctor has recommended bladder removal surgery (radical cystectomy) - You are able to have a pelvic MRI scan **You may NOT be eligible if...** - You have already had your uterus or both ovaries removed - You have cancer that has spread beyond the bladder to distant organs - You have conditions that prevent MRI scanning (such as certain metal implants) - You are not a surgical candidate for other medical reasons Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREReproductive organ sparing radical cystectomy

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

PROCEDURERadical cystectomy

Participants on this arm will undergo a radical cystectomy if they are classified as "unfavorable" based on the decision tool.


Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT06184516


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