Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
Lahey Clinic
Summary
The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- Diagnostic TestUroAmp Test (Convergent Genomics, Inc.)
Non-invasive genomic urine test that can reliably detect, monitor, and predict the risk of urothelial cancer or its recurrence, potentially before signs and symptoms develop or become detectable by historical standards of care.
Location
- Lahey Hospital and Medical CenterBurlington, Massachusetts