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A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
Sponsor: Universal Diagnostics
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.
Key Details
Gender
All
Age Range
45 Years - 84 Years
Study Type
OBSERVATIONAL
Enrollment
12000
Start Date
2024-01-18
Completion Date
2026-12-01
Last Updated
2025-11-10
Healthy Volunteers
Yes
Conditions
Interventions
Signal-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).
Locations (1)
Gastroenterology Consultants of SW Virginia
Raonoke, Virginia, United States