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NCT06184516 · ClinicalTrials.gov registry record · Phase 2
Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy
A Phase 2 study of Urothelial Carcinoma Bladder, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
- 1
- Study location
NCT06184516: Recruiting Phase 2 study of Urothelial Carcinoma Bladder, sponsored by University of Florida.
NCT06184516 is a Phase 2 study of Urothelial Carcinoma Bladder that is actively recruiting participants, run by University of Florida. The registered enrollment target is 147 participants, above the 87-participant average among 16 other Urothelial Carcinoma Bladder trials with a reported enrollment target (69% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06184516, a Phase 2 study of Urothelial Carcinoma Bladder, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Determine the positive margin status rate (based on the surgical pathology report) for the favorable cohort who successfully undergo reproductive organ sparing radical cystectomy
Conditions Studied
Interventions
- PROCEDURE Radical cystectomy
- PROCEDURE Reproductive organ sparing radical cystectomy
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2024-08-30 |
| Est. Completion | 2028-03 |
| Phase | Phase 2 |
What NCT06184516 shows while recruiting
NCT06184516 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 87-participant average among 16 other Urothelial Carcinoma Bladder trials with a reported enrollment target (69% higher).
The record links to 1 condition, with Urothelial Carcinoma Bladder appearing as the primary indexed condition, and to 2 interventions - of which Radical cystectomy is the first listed.
NCT06184516 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06184516 about?
NCT06184516 is a clinical study titled "Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy". 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 ...
What is the current status of trial NCT06184516?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2024-08-30. Estimated completion is 2028-03.
What conditions does trial NCT06184516 study?
This clinical trial studies the following conditions: Urothelial Carcinoma Bladder.
What interventions are being tested in trial NCT06184516?
The interventions under investigation include: Radical cystectomy (PROCEDURE), Reproductive organ sparing radical cystectomy (PROCEDURE).
Who is sponsoring clinical trial NCT06184516?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06184516 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06184516's enrollment target sits among peer trials
147 4th of 16 higher than 13 of 16 other Urothelial Carcinoma Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma Bladder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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