Urine tumor DNA to reduce cystoscopy frequency for non‑muscle invasive bladder cancer

Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer

This trial will test whether a urine tumor DNA (UroAmp) test can let people with non‑muscle invasive bladder cancer who finish induction therapy and have negative post‑treatment checks safely have fewer cystoscopies.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lahey Clinic (Academic / other)
• Locations: 1 site (Burlington, Massachusetts)
• Trial ID: NCT07187063 on ClinicalTrials.gov

What this trial studies

This single-site interventional study uses the UroAmp urine tumor DNA (utDNA) test from Convergent Genomics to guide surveillance frequency in patients with AUA high‑risk non‑muscle invasive bladder cancer who have completed induction intravesical therapy. Eligible participants must have received induction BCG or gemcitabine/docetaxel and have a negative initial post‑induction assessment (negative cytology and cystoscopy with or without biopsy). Participants with negative utDNA results may be offered less frequent cystoscopic surveillance while those with positive utDNA will continue standard monitoring, with regular urine testing and clinical follow‑up to detect recurrence. The study focuses on ensuring that reduced surveillance does not lead to missed recurrences that would alter care.

Who should consider this trial

Good fit: Ideal candidates are adults with AUA high‑risk non‑muscle invasive bladder cancer who have completed induction BCG or gemcitabine/docetaxel and have a negative post‑induction cystoscopy and cytology.

Not a fit: Patients with variant histology, concurrent upper tract disease, positive post‑induction findings, or other listed exclusion criteria are unlikely to qualify or benefit from the de‑intensified surveillance approach.

Why it matters

Potential benefit: If successful, this approach could safely cut the number of invasive cystoscopies, reducing discomfort, clinic visits, and costs for patients.

How similar studies have performed: Early research on urine tumor DNA for detecting bladder cancer recurrence shows promising accuracy, but using utDNA to safely reduce cystoscopy frequency is a newer approach still being tested in clinical trials.

Eligibility criteria

Inclusion Criteria:

* AUA high-risk bladder cancer1
* Received induction BCG or gemcitabine/docetaxel
* Negative initial post-induction therapy assessment (negative cytology and cystoscopy +/- biopsy)

Exclusion Criteria:

* High-risk NMIBC within 3 years
* Prior induction intravesical therapy
* Variant histology
* Concurrent upper tract disease

Where this trial is running

Burlington, Massachusetts

• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Matthew B Clements, MD, MS — Lahey Hospital & Medical Center
• Study coordinator: Linda Topjian

Conditions Non-muscle Invasive Bladder Cancer