Replacing invasive bladder cancer monitoring with urine tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West Haven VA Medical Center
  West Haven, Connecticut, United States Recruiting
• Bay Pines VA Healthcare System
  Bay Pines, 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
• Dartmouth Hitchcock Medical Center
  Lebanon, New Hampshire, United States Recruiting
• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.