This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy.
Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.
Properly counselled patients with high grade T1 disease who elect for cystectomy
Properly counselled patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have elected cystectomy
cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy
Patient who have received prior intravesical therapy or multiple TURBTs can be enrolled (data regarding number of previous TURBTs and type of intravesical therapy will be collected).
Patients who undergo cystectomy with non-curative intent will be excluded.
Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.
Patients who are pregnant or nursing.
Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria. Eligible patients will have bio specimen collected in accordance with the trial protocol.
Case-control
Prospective
Not listed
Utility of a proprietary urine and blood biomarker test for muscle-invasive bladder cancer presence
Determine the utility of a novel, proprietary combined blood and urinary genomic biomarker (ctDNA and cfDNA) 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).
Utility of a DNA test for muscle-invasive bladder cancer presence
Negative predictive value (NPV) of a negative ctDNA and urine-based cfDNA 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.
Accuracy of surgical specimen DNA test to predict muscle-invasive disease
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.
Statistical accuracy evaluation of blood-based ctDNA assay for muscle-invasive bladder cancer presence
Negative predictive value (NPV) of 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.
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Fox Chase Cancer Center
Lead sponsor
Janssen Pharmaceuticals
Collaborator
