Actively Recruiting

Phase 2
Age: 18Years - 99Years
FEMALE
NCT06184516

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

Led by University of Florida · Updated on 2025-09-15

147

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female 18 years of age or older
  • Histologically confirmed urothelial carcinoma of the bladder, including variant histology
  • Candidate for radical cystectomy surgery
  • Ability to undergo pelvic MRI with 1.5T or higher magnet strength including T2 weighted imaging in multiple planes and T1 weighted imaging pre and post contrast (unless contraindicated)
  • Completed cystoscopic evaluation by a urologist within 120 days prior to surgery
  • Completed staging imaging, including pelvic MRI, within 90 days prior to surgery; repeat imaging required after neoadjuvant therapy if given
  • Provided written informed consent and able to comply with study procedures
  • Presence of one or more ancillary reproductive organs (anterior vagina, uterus, fallopian tubes, ovaries)
  • ECOG Performance Status of 0 to 2
Not Eligible

You will not qualify if you...

  • Presence of regional or distant metastatic disease
  • Non-urothelial bladder cancer diagnosis
  • Not a candidate for radical cystectomy surgery
  • Unable to undergo pelvic MRI meeting study standards
  • Subjects of childbearing potential unwilling or unable to use acceptable pregnancy prevention during and for 12 weeks after the study intervention
  • Presence of other active malignancies that could affect recurrence rates
  • Known germline mutations in DNA damage repair genes (BRCA1 or BRCA2)
  • Prisoners or involuntarily incarcerated individuals
  • Subjects detained compulsorily for psychiatric or physical illness treatment
  • Inability to comply with study or follow-up procedures
  • Confirmed pregnancy or breastfeeding
  • Any disease or condition that contraindicates protocol therapy or affects study results per treating physician
  • Receipt of live virus vaccine within 30 days prior to study intervention (non-live vaccines allowed)

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Florida

Gainesville, Florida, United States, 32608

Actively Recruiting

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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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