RecruitingPhase 2NCT05796375

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

Sponsor

White River Junction Veterans Affairs Medical Center

Enrollment

240 participants

Start Date

Nov 17, 2023

Study Type

INTERVENTIONAL

Conditions

Non Muscle Invasive Bladder Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a urine test can replace the need for repeated cystoscopies (a camera exam of the bladder) in monitoring patients with low-grade non-muscle invasive bladder cancer who are at intermediate risk of it coming back. **You may be eligible if...** - You are 18 or older - You have a history of low-grade bladder cancer that has not invaded the muscle layer - Your most recent biopsy showed one of these patterns: multiple small tumors, a single tumor larger than 3 cm, or a recurring tumor - You are willing to follow all study procedures **You may NOT be eligible if...** - Your bladder cancer is high-grade or has invaded the muscle - You do not meet the specific bladder cancer history criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECystoscopy

Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.

DIAGNOSTIC_TESTBladder 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.

DIAGNOSTIC_TESTXpert 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.