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.
Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
At a glance
Conditions
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.
Study leadership
- Florian R Schroeck, MD, MS · PRINCIPAL_INVESTIGATOR · White River Junction VA Healthcare System
Who to contact
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Inclusion
What this trial measures
- 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.