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

NCT06059963 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 12000

Last updated 2025-11-10

No results posted yet for this study

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.

Conditions

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).

Sponsors & Collaborators

  • Universal Diagnostics

    lead INDUSTRY

Eligibility

Min Age
45 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2026-10-30
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059963 on ClinicalTrials.gov