Signal-C Test Evaluation for Colorectal Cancer Screening

This study is evaluating a new test called Signal-C™. This test uses a blood sample to look for signs of colorectal cancer and advanced precancerous lesions (growths that could become cancer). We want to see how well Signal-C™ can find these conditions in people aged 45 to 84 who are considered to have an 'average risk' for colorectal cancer. To join, you would need to be between 45 and 84 years old and planning to have a standard colonoscopy. The study aims to enroll 12,000 participants. The current recruitment status is unclear, but the main goal is to see how well the Signal-C™ test performs over one year.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It aims to include 12,000 participants.
What's involved
You would need to provide a blood sample before your colonoscopy, ideally within 90 days of the blood draw.
Compensation
Not stated in the trial record.
Follow-up
The primary objective is measured at 1 year.

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NCT06059963

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

Recruiting
Not specifiedAges 45–84Observational
Universal Diagnostics
~12,000 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Signal-C™

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Objective
Measured over 1 year
Colorectal Cancer
Advanced Adenocarcinoma
1 sites across 1 states
Virginia1

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  • Primary Objective1 year

    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).