Offering a New Way to Check for Early Bladder Cancer Using Urine Tests
NCT05796375 · RecruitingThis research looks at whether bladder cancer checks can be better by using urine tests instead of some cystoscopy procedures. The study focuses on early-stage bladder cancer. It aims to find out if there are differences in symptoms, discomfort, anxiety, and cancer outcomes when urine tests replace cystoscopy.
Locations and contact
This trial is running at 9 locations in the United States. 8 of them are currently recruiting.
United States9 locations · 8 recruiting
- Bay Pines VA Healthcare SystemBay Pines, FloridaRecruiting
- James A. Haley Veterans' HospitalTampa, FloridaRecruiting
- University Hospitals Cleveland Medical CenterCleveland, OhioRecruiting
- UT Southwestern Medical CenterDallas, TexasRecruiting
- VA Boston Jamaica Plains CampusWest Roxbury, MassachusettsRecruiting
- VA St.Louis Healthcare SystemSt Louis, MissouriRecruiting
- West Haven VA Medical CenterWest Haven, ConnecticutRecruiting
- White River Junction Veterans Healthcare SystemWhite River Junction, VermontRecruiting
- Medical University of South CarolinaCharleston, South CarolinaActive Not Recruiting
Who can join
Adults aged 18 and older can join. You should have a history of low-grade non-muscle invasive bladder cancer. You also need to be willing to follow study procedures and be available for the study's duration. Those with certain medical histories or conditions, like total bladder removal, cannot join. The trial team will confirm eligibility.
What happens during the trial
Participants will be placed into three groups by chance. One group will have frequent cystoscopy checks. The second group will have urine tests using the Xpert Bladder Cancer Monitor and some cystoscopy. The third group will use the Bladder EpiCheck test along with cystoscopy. Everyone will be followed for 24 months to monitor their health and outcomes.
The trial team
The trial is sponsored by the White River Junction Veterans Affairs Medical Center. Dr. Florian R Schroeck is the principal investigator. Other partners include the National Cancer Institute, University of Texas Southwestern Medical Center, and Medical University of South Carolina.
Important dates
The trial started on November 17, 2023. It is expected to finish by December 30, 2028. The study is currently enrolling new participants.
Additional information
This is a Phase 2 trial, which means it is looking at how well the urine tests work compared to cystoscopy. The trial is not for any FDA-regulated drugs but does involve a regulated device. About 240 participants will be included.
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