New tool may spare women unnecessary organ removal during bladder cancer surgery
NCT ID NCT06184516
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times
Summary
This study tests a decision tool to help select women with bladder cancer who can safely keep their reproductive organs during bladder removal surgery. Currently, standard surgery removes the bladder, uterus, ovaries, and part of the vagina, which can harm sexual health, mental health, and increase heart and bone risks. The tool uses MRI and cystoscopy to identify low-risk patients, aiming to preserve quality of life without compromising cancer control. About 127 women will participate.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 127 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Florida
RECRUITINGGainesville, Florida, 32608, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New combo aims to wipe out rare bladder cancer before surgery
- Bladder cancer patients may avoid surgery with new drug
- New combo therapy for bladder cancer passes first safety test?
- Experimental combo aims to supercharge cancer immunotherapy
- Step up to surgery: daily walks may cut bladder cancer operation risks