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. This is a prospective
non-interventional study to collect definitive evidence of the safety and effectiveness of
C2i-Test for the intended use, in a statistically justified number of subjects.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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