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Spots Global Cancer Trial Database for Clinical Performance Evaluation of the C2i Test

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Trial Identification

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

Interventions

C2i-WGS-MRD Test

Study Description

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.

Eligibility

Minimum Age: 22 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Yair Lotan, MD

Affiliation: UT Southwestern Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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