Decision tool for selecting women for bladder surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates a decision-making tool designed to identify female patients with urothelial carcinoma who may be eligible for a gynecologic sparing radical cystectomy. The study aims to reduce unnecessary removal of reproductive organs, which can lead to significant quality of life issues and health risks. By utilizing pre-operative imaging and risk factor assessments, the trial seeks to improve surgical outcomes while preserving reproductive health. The approach is based on retrospective reviews that highlight specific risk factors associated with bladder cancer involvement in female reproductive organs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with regional or distant metastatic disease
* Non-urothelial bladder cancer.
* Not a surgical candidate for radical cystectomy
* Unable to have MRI of pelvis that meets the minimum standards in the inclusion criteria above.
* 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.

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Tarik Benidir, MD — University of Florida
• Study coordinator: Nicole Davila Torres
• Email: ndavilatorres@ufl.edu
• Phone: 352-273-6913

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.