RECRUITINGINTERVENTIONAL
Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- AUA high-risk bladder cancer1
- Received induction BCG or gemcitabine/docetaxel
- Negative initial post-induction therapy assessment (negative cytology and cystoscopy +/- biopsy)
Who Should NOT Join This Trial:
- High-risk NMIBC within 3 years
- Prior induction intravesical therapy
- Variant histology
- Concurrent upper tract disease
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIAGNOSTIC_TEST
UroAmp 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.
Locations (1)
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States