A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
Summary
To evaluate the performance characteristics of Signal-C™ a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions (APL) in an average risk screening population for 45 and over.
Arms & interventions
- DeviceSignal-C™
Signal-C™ is a qualitative next generation sequencing-based in vitro diagnostic assay that uses targeted hybridization-based capture next-generation sequencing together with bioinformatics and machine learning algorithm for detection and combination of methylation and fragmentation associated DNA marker regions. Signal-C™ utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected via venipuncture in Streck Cell-Free DNA Blood Collection Tubes (BCTs).
Outcome measures
Primary
Primary Objective
The primary objective of this study is to determine the sensitivity for CRC and specificity for advanced neoplasia (AN). Advance Neoplasia (AN) is defined as a final diagnosis of CRC or Advanced Precancerous Lesion (APL).
Time frame: 1 year
Secondary
Secondary Objective
Time frame: 1 year
Eligibility criteria
Study locations (1)
Gastroenterology Consultants of SW Virginia
Raonoke, Virginia, 24014