NCT05221827

Clinical Performance Evaluation of the C2i-Test

Clinical Performance Evaluation of the C2i-Test for Detecting Molecular Residual Disease (MRD) in Bladder Cancer Patients.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: C2i Genomics · Industry
• Sex: All
• Age: 22 Years – 100 Years
• Healthy volunteers: —

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

Type	Name	Description
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).

Timeline

• Start date: 2022-02-24
• Primary completion: 2022-07-27
• Completion: 2022-07-27
• First posted: 2022-02-03
• Last updated: 2023-02-27

Locations

1 site across 1 country: United States