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RECRUITING Phase 2 ClinicalTrials.gov

Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance

Sponsor: White River Junction Veterans Affairs Medical Center • ClinicalTrials.gov ID: NCT05796375

Registry updated: 2026-09-16
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Description

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.

Interventions

  • Cystoscopy (Procedure)
    Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.
  • Bladder EpiCheck urine test (Diagnostic 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 (Diagnostic 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.

Eligibility criteria

Inclusion Criteria: 1. Aged 18 years or older 2. History of low grade intermediate-risk non-muscle invasive bladder cancer, defined as most recent pathology report showing any of the following: * multifocal low grade non-invasive urothelial carcinoma of any size * solitary low grade non-invasive urothelial carcinoma greater than 3cm in size * recurrent low grade non-invasive urothelial carcinoma 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. No evidence for recurrence at cystoscopy ≤6 months after most recent tumor resection 5. Ability to consent in English or Spanish Exclusion Criteria: 1. History of total cystectomy of the bladder. 2. History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit). 3. History of muscle-invasive bladder tumor. 4. Pregnancy or lactation. 5. History of urothelial carcinoma of the ureter or renal pelvis status post endoscopic treatment or with evidence of recurrent upper tract disease (inclusion allowed if status post nephroureterectomy and recurrence free at time of inclusion) 6. Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture). 7. Inability to provide a voided urine sample.

Conditions

Non-muscle-invasive Bladder Cancer

Locations

  • West Haven VA Medical Center — West Haven, Connecticut, United States
  • Bay Pines VA Healthcare System — Bay Pines, Florida, United States
  • James A. Haley Veterans' Hospital — Tampa, Florida, United States
  • VA Boston Jamaica Plains Campus — West Roxbury, Massachusetts, United States
  • VA St.Louis Healthcare System — St Louis, Missouri, United States
  • Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record