Back to search results

Decision Tool for Organ-Sparing Surgery in Bladder Cancer

This study is looking at a new way to decide which women with bladder cancer (urothelial carcinoma of the bladder) can have a surgery that spares their reproductive organs. Currently, standard surgery removes the bladder and reproductive organs like the uterus and ovaries, which can affect quality of life. This study will use a decision tool to guide treatment. If the tool classifies you as "favorable," you'll have a reproductive organ sparing radical cystectomy. If "unfavorable," you'll have the standard radical cystectomy. Researchers will check the positive margin rate (if cancer cells are found at the edge of the removed tissue) 120 days after surgery. They plan to enroll 127 women aged 18 to 99 who are candidates for bladder removal surgery and can have a pelvic MRI.

Study design
This is an interventional study involving 127 women. Participants will be assigned to one of two surgical procedures based on a decision tool.
What's involved
You would undergo a radical cystectomy, either with or without reproductive organ sparing, and have a pelvic MRI. The study will measure positive margin rate 120 days after surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, positive margin rate, will be measured 120 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06184516

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

Recruiting
PHASE2Ages 18–99InterventionalTreatment
University of Florida
~127 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Reproductive organ sparing radical cystectomyRadical cystectomy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Positive margin rate
Measured over 120 days

Conditions

Urothelial Carcinoma Bladder

Explore related trials

Urothelial Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Tarik Benidir, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Nicole Davila Torres
[email protected]
352-273-6913
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Female ≥ eighteen years of age
Histologically proven diagnosis of urothelial carcinoma of the bladder, including variant histology
Surgical candidate for radical cystectomy
Be able to undergo pelvic MRI. Minimum standards for MRI imaging will include the following:
MRI of the pelvis on 1.5T or higher strength magnet.
T2 weighted imaging in multiple planes.
T1 weighted imaging pre and post contrast administration (unless contrast is contraindicated by allergy or renal insufficiency)
Cystoscopic evaluation completed by urologist within 120 days prior to surgery (ROS-RC or RC)
Staging imaging within 90 days prior to surgery (ROS-RC or RC). If receiving neoadjuvant therapy prior to surgery (ROS-RC or RC), repeat staging imaging must be completed after the neoadjuvant therapy is completed, or no longer tolerated by the patient.
Staging imaging must include MRI of the pelvis within 90 days of surgery (ROS-RC or RC)
Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.
Presence of at least one or more ancillary organs. Ancillary organs defined as anterior vagina, uterus, fallopian tubes (only 1 tube present will be considered at physician discretion), and ovaries.
ECOG Performance Status of 0-2
Subjects of childbearing potential (SOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during study intervention and for at least 12 weeks after the study intervention.
Patients with other known active malignancies which may confound the recurrence rates
Patients with known germline mutations in DNA damage repair genes (BRCA1/BRCA 2)
Prisoners or subjects who are involuntarily incarcerated.
Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
Subjects who are confirmed to be pregnant or breastfeeding.
History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for complications, in the opinion of the treating physician.
Administration of a vaccine containing live virus within 30 days prior to the study intervention. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID vaccine are allowed.

Exclusion

Patients with regional or distant metastatic disease
Non-urothelial bladder cancer.
Not a surgical candidate for radical cystectomy

What this trial measures

  • Positive margin rate120 days

    Determine the positive margin status rate (based on the surgical pathology report) for the favorable cohort who successfully undergo reproductive organ sparing radical cystectomy