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: Clinical Performance Evaluation of the C2i-Test for Detecting Molecular Residual Disease (MRD) in Bladder Cancer Patients.
Study ID: NCT05221827
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 22 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
New Jersey Urology, Bloomfield, New Jersey, United States
Contact Details
Name: Yair Lotan, MD
Affiliation: UT Southwestern
Role: PRINCIPAL_INVESTIGATOR
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