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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Advanced Adenocarcinoma
• Intervention / Treatment: Device: Signal-C™

• Study Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: Kara Mattox; Phone Number: (+1)3392085320; Email: kara.mattox@universaldx.com

Study Locations

• United States
  • Virginia
    • Raonoke, Virginia, United States, 24014
      • Recruiting
      • Gastroenterology Consultants of SW Virginia
      • Contact: Vishal Bhagat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 45 and 84, who are at average risk of developing colorectal cancer, and are scheduled for a standard-of-care screening colonoscopy.

Approximately 12,000 subjects will need to be enrolled. Enrollment is event-driven and will be stopped when the required number of CRC cases have been confirmed with a final histopathological diagnosis.

Description

Inclusion Criteria:

1. Subjects aged 45-84 years at time of consent
2. Intended to undergo a standard-of-care screening colonoscopy
3. Considered by a physician or healthcare provider as being of 'average risk' for CRC
4. Willing to consent to blood draw prior to bowel preparatory procedures or undergoing colonoscopy ideally within 90 days of the date of the investigational blood draw.
5. Willing to consent to follow-up for one year as per protocol
6. Able and willing to sign informed consent

Exclusion Criteria:

1. Undergoing colonoscopy for investigation of CRC risk symptoms
2. Has undergone colonoscopy within preceding 9 years
3. Positive FIT/FOBT result within the previous 12 months (+/- 3 months)
4. Has completed Cologuard or Epi proColon testing within the previous 3 years.
5. Has undergone a CT colonography in the prior 4 years.
6. History of colorectal cancer.
7. History of any malignancy within prior 5 years.
8. Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).
9. Positive family history of colorectal cancer, defined as having a first- degree relative (parent, sibling, or child) with CRC diagnosed at age <60 years or with more than one first-degree relative diagnosed with CRC at any age.
10. Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC [HNPCC], or Familial Adenomatous Polyposis [FAP]).
11. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.
12. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
13. Known pregnancy at informed consent, blood sample collection, and during study participation.
14. Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Average risk; Patients aged between 45 and 84, who are at average risk of developing colorectal cancer, and are scheduled for a standard-of-care screening colonoscopy.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	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).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Objective	To determine sensitivity for advanced precancerous lesions (APL). To determine NPV and PPV for colorectal cancer.	1 year

Collaborators and Investigators

• Sponsor: Universal Diagnostics
• Collaborators: Premier Research Group plc; Science 37; Yanuvia, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Advanced Precancerous Lesions
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CRC-US-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No