Urine tumor DNA to reduce cystoscopy frequency for non‑muscle invasive bladder cancer
Official title: Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
Run by Lahey Clinic · NCT07187063 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Lahey Clinic Academic / other |
| Locations | 1 site (Burlington, Massachusetts) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | January 1, 2029 |
| Study ends | January 1, 2029 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07187063 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: Linda.M.Topjian@lahey.org
- Phone: 7817448420
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Alpha1H before bladder tumor surgery in low/intermediate risk non-muscle-invasive bladder cancer
This trial tests whether putting Alpha1H directly into the bladder before standard surgery helps prevent cancer from coming back or getting worse in adults with low- to intermediate-risk non-muscle-invasive bladder cancer.
-
Active surveillance versus single-dose intravesical chemo after TURBT in low-shedding intermediate-risk NMIBC
This study tests whether some patients with intermediate-risk non-muscle-invasive bladder cancer can skip additional bladder chemotherapy after complete tumor removal if urine tests show a low-shedding profile.
-
LCS103 Herbal Formula for Preventing NMIBC Recurrence
This study tests whether the LCS103 herbal formula added to standard care can help prevent bladder cancer recurrence in adults with non-muscle invasive bladder cancer.
-
Intravesical UGN-501 for Recurrent NMIBC (Phase 1, dose-escalation)
This study tests whether UGN-501 can be safely given into the bladder to treat adults with recurrent non-muscle invasive bladder cancer.
-
Disitamab Vedotin plus Mitomycin C for HER2-positive high-risk NMIBC
This study tests whether giving disitamab vedotin through the bloodstream together with bladder-delivered mitomycin C can help people with HER2-expressing, high-risk non-muscle-invasive bladder cancer.
-
Sexual health support after bladder cancer treatment
This project will try sexological support to help adults about 12 months after bladder cancer treatment improve sexual function and intimacy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.