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

May 1, 2026 updated by: Florian Schroeck, White River Junction Veterans Affairs Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multi-site randomized phase 2 trial including 240 patients with early-stage bladder cancer, in which patients will be randomized 1:1:1 to programmatic surveillance with the Xpert bladder cancer urine test, the Bladder EpiCheck urine test, or frequent cystoscopy. The primary outcome will be urinary quality of life measured 1 to 3 days after surveillance.

This study will have three groups, also called "arms": (1) Frequent Cystoscopy Arm, (2) Xpert Urine Test Arm, and (3) Epicheck Urine Test Arm. The aim of Frequent Cystoscopy is to detect any cancer that might have come back within the bladder by frequently inspecting the bladder. Those in the cystoscopy arm will have a cystoscopy procedure at specified time points for two years. The goal of the Xpert Urine Test arm is to detect any cancer that might have come back within the bladder, while decreasing the number of invasive cystoscopy procedures. Those in the Xpert arm will have a Xpert urine test and a check-up with a medical doctor at 6 months and 18 months, and have a cystoscopy procedure at 12 months and 24 months. The aim of the EpiCheck Urine Test arm is to detect any cancer that might have come back within the bladder, while decreasing the number of invasive cystoscopy procedures. Those in the EpiCheck Urine Test arm will have an Epicheck urine test and a check-up with a medical doctor at 6 months and 18 months and will have a cystoscopy procedure at 12 months and 24 months. The study performance period is 24 months.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • Recruiting
        • West Haven VA Medical Center
        • Contact:
        • Principal Investigator:
          • Fady Ghali, MD
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Recruiting
        • Bay Pines VA Healthcare System
        • Principal Investigator:
          • Andrew Leone, MD
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • James A. Haley Veterans' Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cesar E Ercole, MD
    • Massachusetts
      • West Roxbury, Massachusetts, United States, 02132
        • Recruiting
        • VA Boston Jamaica Plains Campus
        • Contact:
        • Sub-Investigator:
          • Lori Lerner, MD
    • Missouri
      • St Louis, Missouri, United States, 63016
        • Recruiting
        • VA St.Louis Healthcare System
        • Contact:
        • Principal Investigator:
          • Lewis Thomas, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Randy Vince, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Active, not recruiting
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75235
    • Vermont
      • White River Junction, Vermont, United States, 05009
        • Recruiting
        • White River Junction Veterans Healthcare System
        • Principal Investigator:
          • Florian R Schroeck, MD, MS
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: Cystoscopy
Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.
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
Procedure: Cystoscopy
Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.
Diagnostic test: 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.
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.
Procedure: Cystoscopy
Cystoscopy entails direct inspection of the bladder via a cystoscope that is inserted into a patient's urethra.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Questionnaire-Non-Muscle Invasive Bladder Cancer 24 (EORTC QLQ-NMIBC24)
Time Frame: Assessed at 3, 6, 12, 18, and 24 months.
Measuring change from baseline. Score range: 0-100. Lower score indicates higher quality of life.
Assessed at 3, 6, 12, 18, and 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

White River Junction Veterans Affairs Medical Center

Collaborators

Medical University of South Carolina
National Cancer Institute (NCI)
University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Florian R Schroeck, MD, MS, White River Junction VA Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1732756
  • R37CA275916 (U.S. NIH Grant/Contract)
  • 1R37CA275916-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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