Clinical Performance Evaluation of the C2i Test

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05860543
Study type	Observational
Source	University of Texas Southwestern Medical Center
Contact	Jacob Taylor, MD
Phone	214-645-8791
Email	Jacob.Taylor@UTSouthwestern.edu
Status	Not yet recruiting
Phase
Start date	August 1, 2024
Completion date	June 1, 2025

View Details

See also
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