Replacing invasive bladder cancer monitoring with urine tests
Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
This study is testing if urine tests can replace some bladder cancer check-ups that usually require invasive procedures, to see if they can still keep patients safe while making their experience easier.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | White River Junction Veterans Affairs Medical Center Federal |
| Locations | 9 sites (West Haven, Connecticut and 8 other locations) |
| Trial ID | NCT05796375 on ClinicalTrials.gov |
What this trial studies
This research aims to improve bladder cancer surveillance by substituting some cystoscopy procedures with urine testing. The study involves 240 patients with early-stage bladder cancer who will be randomly assigned to one of three groups: frequent cystoscopy, Xpert urine test, or Bladder EpiCheck urine test. The primary outcome is to assess urinary quality of life shortly after surveillance procedures. The goal is to determine if urine tests can reduce the need for invasive cystoscopy while maintaining effective cancer monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of low-grade intermediate-risk non-muscle invasive bladder cancer.
Not a fit: Patients with a history of total cystectomy, muscle-invasive bladder tumors, or those currently pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less invasive monitoring for bladder cancer, improving patient comfort and reducing anxiety.
How similar studies have performed: Other studies have shown promise in using urine tests for bladder cancer monitoring, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
West Haven, Connecticut and 8 other locations
- West Haven VA Medical Center — West Haven, Connecticut, United States (Recruiting)
- Bay Pines VA Healthcare System — Bay Pines, Florida, United States (Recruiting)
- James A. Haley Veterans' Hospital — Tampa, Florida, United States (Recruiting)
- VA Boston Jamaica Plains Campus — West Roxbury, Massachusetts, United States (Recruiting)
- VA St.Louis Healthcare System — St Louis, Missouri, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Active_not_recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- White River Junction Veterans Healthcare System — White River Junction, Vermont, United States (Recruiting)
Study contacts
- Principal investigator: Florian R Schroeck, MD, MS — White River Junction VA Healthcare System
- Study coordinator: Prabhavathi Loganathan, MS
- Email: Prabhavath.Loganathan@va.gov
- Phone: 802-295-9363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.