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

Recruiting now · Phase 2

Conditions studied: Non-muscle-invasive Bladder Cancer

In brief

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.

Key facts

Study ID

NCT05796375

Run by

White River Junction Veterans Affairs Medical Center

People needed

240

Starts

2023-11-17

Expected to finish

2028-12-30

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years or older
• 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
• Stated willingness to comply with all study procedures and availability for the duration of the study
• No evidence for recurrence at cystoscopy ≤6 months after most recent tumor resection
• Ability to consent in English or Spanish

You may not qualify if…

• History of total cystectomy of the bladder.
• History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit).
• History of muscle-invasive bladder tumor.
• Pregnancy or lactation.
• 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)
• Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).
• Inability to provide a voided urine sample.

Where it is running

• White River Junction Veterans Healthcare System — White River Junction, Vermont, United States (enrolling)
• Bay Pines VA Healthcare System — Bay Pines, Florida, United States (enrolling)
• James A. Haley Veterans' Hospital — Tampa, Florida, United States (enrolling)
• VA Boston Jamaica Plains Campus — West Roxbury, Massachusetts, United States (enrolling)
• VA St.Louis Healthcare System — St Louis, Missouri, United States (enrolling)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• West Haven VA Medical Center — West Haven, Connecticut, United States (enrolling)
• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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