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Brief Title: Clinical Performance Evaluation of the C2i Test
Official Title: Multi-Institutional Evaluation of C2i-Test Performance for Detecting Molecular Residual Disease (MRD) in Muscle-invasive Bladder Cancer Patients Undergoing Radical Cystectomy.
Study ID: NCT05860543
Brief Summary: The overall objective of this study is to demonstrate the safety and effectiveness by means of investigation of the ability of C2i-Test to predict 2-year recurrence-free survival post-RC in stage II-IIIA MIBC patients.
Detailed Description: This is a prospective non-interventional study to evaluate the specificity of the C2i-Test in predicting 2-year recurrence-free survival post- definitive treatment (RC/RC + adjuvant chemotherapy), compared to the gold standard (GS) diagnosis as determined by patient outcome (based on NCCN guidelines). The C2i-WGS-MRD Test (hereinafter referred to as C2i-Test), a personalized molecular circulating tumor DNA (ctDNA) test, is an in vitro qualitative test that uses next generation sequencing (NGS) based whole-genome sequencing (WGS) data for detecting molecular residual disease (MRD) in patients diagnosed with muscle-invasive bladder cancer (MIBC) and histopathologically classified as stage II-IIIA. The C2i-Test is a single site assay performed in the C2i Genomics' CLIA-certified laboratory.
Minimum Age: 22 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Yair Lotan, MD
Affiliation: UT Southwestern Medical Center
Role: PRINCIPAL_INVESTIGATOR