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Recruiting
NCT05796375
Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
Conditions: Non-muscle-invasive Bladder Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 240
Sponsor: White River Junction Veterans Affairs Medical Center
Location: West Haven VA Medical Center West Haven Connecticut
Summary
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.
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.
Source: ClinicalTrials.gov (NCT05796375). StuddyBuddy aggregates publicly available trial information.