Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Open
Phase: II
Principal Investigator: Schober, Jared
Contact Information:
Heather Mittelstedt
hmittelstedt@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06396533?term=NCT06396533&rank=1#participation-criteria
Summary
1. Determine the utility of a biomarker ctDNA assay in predicting the presence or absence of a muscle-invasive bladder cancer at cystectomy when no disease is identified on systematic endoscopic evaluation (SEE, aka seeT0).
2.2. Primary Endpoint:
1. Negative predictive value (NPV) of a negative blood-based ctDNA assay to determine the presence or absence of muscle-invasive bladder cancer (pTmi0) on final cystectomy pathology in patients undergoing radical cystectomy with a pre-surgical seeT0 bladder.
2.3. Secondary Objective:
1. Determine the accuracy of a negative blood-based ctDNA assay combined with a urinary genomic cfDNA assay to predict the presence or absence of muscle-invasive disease in cystectomy surgical specimen.
2.4. Secondary Endpoints:
1. Negative predictive value (NPV) of a combined blood-based ctDNA assay and urinary cfDNA assay to determine the presence or absence of muscle-invasive bladder cancer (pTmi0) on final cystectomy pathology in patients undergoing radical cystectomy.