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RECRUITING
NCT06059963

A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation

Sponsor: Universal Diagnostics

View on ClinicalTrials.gov

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

Interventions

DEVICE

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