Clinical Performance Evaluation of the C2i-Test

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.

Conditions

• Muscle-Invasive Bladder Carcinoma

Interventions

DIAGNOSTIC_TEST

C2i Test

The 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).

Sponsors & Collaborators

• New Jersey Urology

  collaborator UNKNOWN

• University of Texas

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• NY Health d/b/a New York Cancer and Blood Specialists

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Fox Chase Cancer Center

  collaborator OTHER

• New York University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• C2i Genomics

  lead INDUSTRY

Principal Investigators

• Yair Lotan, MD · UT Southwestern

Eligibility

Min Age

22 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-24

Primary Completion

2022-07-27

Completion

2022-07-27

Countries

• United States

Study Locations