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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
56
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.
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
RECRUITINGNumber of cystoscopies
The rate of cystoscopies (cystoscopies per month), compared between the De-intensified and the standard surveillance arms, is the primary outcome measure.
Time frame: From enrollment to 24 months
Event-free survival
An event is defined as: high-grade recurrence, progression to muscle invasive disease, or metastatic disease
Time frame: From enrollment to 24 months
Recurrence-free survival
We will compare the rate of any recurrences (including low-grade) between the De-intensified and the standard surveillance groups
Time frame: From enrollment to 24 months
Patient-reported outcomes
The National Comprehensive Cancer Network Distress thermometer and the European Organisation For Research And Treatment Of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Non-Muscle Invasive Bladder Cancer (NMIBC-24) Module will be collected and compared between study arms
Time frame: From enrollment to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.