RecruitingNCT06059963

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

Sponsor

Universal Diagnostics

Enrollment

12,000 participants

Start Date

Jan 18, 2024

Study Type

OBSERVATIONAL

Conditions

Colorectal, Cancer Advanced Adenocarcinoma

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.

Eligibility

Min Age: 45 YearsMax Age: 84 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new blood test called Signal-C to see how well it can detect colorectal cancer or pre-cancerous growths, compared to a standard colonoscopy in average-risk patients. **You may be eligible if...** - You are between 45 and 84 years old - You are scheduled for a routine screening colonoscopy - Your doctor considers you to be at average risk for colorectal cancer - You are willing to have a blood draw before your colonoscopy - You are willing to follow up for one year **You may NOT be eligible if...** - You are outside the 45-84 age range - You are considered high risk for colorectal cancer - You are unwilling to provide a blood sample or consent to follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).

Locations(1)

Gastroenterology Consultants of SW Virginia

Raonoke, Virginia, United States

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NCT06059963

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