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Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Cystoscopy (procedure)
- Bladder EpiCheck urine test (diagnostic test)
- Xpert Bladder Cancer Monitor urine test (diagnostic test)
Sponsor: White River Junction Veterans Affairs Medical Center · Participants: 240 · Started: Nov 17, 2023
Contact the study team
- Prabhavathi Loganathan, MS · Phone: 802-295-9363
- Laura Jensen, MPH · Phone: 802-280-5298
Official record on ClinicalTrials.gov — NCT05796375
Locations in the U.S.
| Connecticut | West Haven VA Medical Center, West Haven |
| Florida | Bay Pines VA Healthcare System, Bay Pines |
| Massachusetts | VA Boston Jamaica Plains Campus, West Roxbury |
| Missouri | VA St.Louis Healthcare System, St Louis |
| New Hampshire | Dartmouth Hitchcock Medical Center, Lebanon |
| Ohio | University Hospitals Cleveland Medical Center, Cleveland |
| Texas | UT Southwestern Medical Center, Dallas |
| Vermont | White River Junction Veterans Healthcare System, White River Junction |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.