Replacing Cystoscopy with Urine Tests for Non-muscle Invasive Bladder Cancer Surveillance

This study is looking at whether urine tests can replace some cystoscopy procedures (a direct inspection of the bladder) for monitoring non-muscle invasive bladder cancer. You may be eligible if you are 18 or older and have a history of low-grade intermediate-risk non-muscle invasive bladder cancer. The study aims to see if using the Bladder EpiCheck or Xpert Bladder Cancer Monitor urine tests instead of frequent cystoscopy can improve your quality of life, reduce discomfort and anxiety, and decrease the number of invasive procedures, while still effectively detecting cancer recurrence or progression. The study is currently unclear on its recruitment status and plans to enroll 240 patients.

Study design
This is a randomized Phase 2 study with 240 participants. You would be assigned to one of three groups: frequent cystoscopy, Xpert urine test, or Bladder EpiCheck urine test.
What's involved
Depending on your assigned group, you would have either frequent cystoscopy procedures or a combination of urine tests and fewer cystoscopies over two years. You will also complete quality of life questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be assessed at 3, 6, 12, 18, and 24 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05796375

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

Recruiting
PHASE2Ages 18+InterventionalHealth services
White River Junction Veterans Affairs Medical Center
~240 participants
Updated 2026-09-16 on ClinicalTrials.gov
What's tested:CystoscopyBladder EpiCheck urine testXpert Bladder Cancer Monitor urine test

At a glance

Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quality of Life Questionnaire-Non-Muscle Invasive Bladder Cancer 24 (EORTC QLQ-NMIBC24)
Measured over Assessed at 3, 6, 12, 18, and 24 months.
Non-muscle-invasive Bladder Cancer

NCT05796375

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Bay Pines VA Healthcare System

    Bay Pines, Floridastudy coordinator listed

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshirestudy coordinator listed

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

  • VA Boston Jamaica Plains Campus

    West Roxbury, Massachusettsstudy coordinator listed

    Recruiting

  • VA St.Louis Healthcare System

    St Louis, Missouristudy coordinator listed

    Recruiting

  • West Haven VA Medical Center

    West Haven, Connecticutstudy coordinator listed

    Recruiting

  • White River Junction Veterans Healthcare System

    White River Junction, Vermontstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Florian R Schroeck, MD, MS · PRINCIPAL_INVESTIGATOR · White River Junction VA Healthcare System

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Eligibility criteria

Inclusion

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

    Measuring change from baseline. Score range: 0-100. Lower score indicates higher quality of life.