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.
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.