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Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
Sponsor: White River Junction Veterans Affairs Medical Center
Summary
The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with urine testing. Specifically, this study examines whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2023-11-17
Completion Date
2028-12-30
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
Cystoscopy
Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.
Bladder EpiCheck urine test
The Bladder EpiCheck is a laboratory-developed test for early-stage non-muscle invasive bladder cancer. The Bladder EpiCheck test is a DNA methylation test that is run on DNA extracted from cell pellet from centrifuged urine according to Standardized Operating Procedures. The test has internal controls and a dedicated software to ensure required quality assurance processes and prompt reporting of results.
Xpert Bladder Cancer Monitor urine test
A 4.5 ml sample of voided urine is added to Xpert® Urine Transport Reagent, mixed, and then 4ml of treated urine are transferred to the Sample Chamber of the cartridge. In the cartridge, cells in the urine sample are captured on a filter and lysed by sonication. The released nucleic acid is eluted, mixed with dry RT-PCR reagents, and the solution is transferred to the reaction tube for RT-PCR and detection.
Locations (8)
West Haven VA Medical Center
West Haven, Connecticut, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
VA Boston Jamaica Plains Campus
West Roxbury, Massachusetts, United States
VA St.Louis Healthcare System
St Louis, Missouri, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
White River Junction Veterans Healthcare System
White River Junction, Vermont, United States