Recruiting
Phase 2

Urine Testing

Sponsor:

White River Junction Veterans Affairs Medical Center

Code:

NCT05796375

Conditions

Non-muscle-invasive Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cystoscopy

Bladder EpiCheck urine test

Xpert Bladder Cancer Monitor urine test

Study Details

Brief 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.

Conditions

Non-muscle-invasive Bladder Cancer

Study ID

NCT05796375

Start date

Nov 17, 2023

Status verified date

Aug, 2026

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Frequent Cystoscopy

Cystoscopy is conducted at 6, 12, 18, and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer

experimental: Xpert Urine Test

Xpert arm includes urine testing using the Xpert Bladder Cancer Monitor urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer

experimental: EpiCheck Urine Text

EpiCheck arm includes urine testing using the Bladder EpiCheck urine test at 6 and 18 months. Cystoscopy is conducted at 12 and 24 months for patients undergoing surveillance for low grade intermediate-risk non-muscle invasive bladder cancer.

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.

Primary outcome measure

  • Quality of Life Questionnaire-Non-Muscle Invasive Bladder Cancer 24 (EORTC QLQ-NMIBC24) [ Time Frame: Assessed at 3, 6, 12, 18, and 24 months. ]

Central Contacts and Locations

Central contacts

Locations

West Haven VA Medical Center

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Principal Investigator:

Preston Sprenkle, MD

Bay Pines VA Healthcare System

Recruiting

Bay Pines, Florida, United States, 33744

Contacts

Principal Investigator:

Andrew Leone, MD

James A. Haley Veterans' Hospital

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Cesar E Ercole, MD

VA Boston Jamaica Plains Campus

Recruiting

West Roxbury, Massachusetts, United States, 02132

Contacts

Principal Investigator:

Jeffrey Ellis, MD

VA St.Louis Healthcare System

Recruiting

St Louis, Missouri, United States, 63016

Contacts

Principal Investigator:

Lewis Thomas, MD

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Laura Tafe, MD

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Randy Vince, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

Yair Lotan, MD

White River Junction Veterans Healthcare System

Recruiting

White River Junction, Vermont, United States, 05009

Contacts

Principal Investigator:

Florian R Schroeck, MD, MS

More Information

Sponsor

White River Junction Veterans Affairs Medical Center

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Bladder
  • Cancer
  • Urology
  • Cystoscopy
  • Xpert
  • EpiCheck
  • Urine test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by White River Junction Veterans Affairs Medical Center on 2026-08-05.