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

NCT06059963 | Recruiting FDA Device

• 1 other identifier: CRC-US-003
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer; Advanced Adenocarcinoma

Keywords

Advanced Precancerous Lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Objective

  1 year

Study Arms (1)

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™

Interventions

Signal-C™ DEVICE

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).

Average risk

Eligibility Criteria

• Age: 45 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects aged 45-84 years at time of consent
• Intended to undergo a standard-of-care screening colonoscopy
• Considered by a physician or healthcare provider as being of 'average risk' for CRC
• 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.
• Willing to consent to follow-up for one year as per protocol
• Able and willing to sign informed consent

You may not qualify if:

• Undergoing colonoscopy for investigation of CRC risk symptoms
• Has undergone colonoscopy within preceding 9 years
• Positive FIT/FOBT result within the previous 12 months (+/- 3 months)
• Has completed Cologuard or Epi proColon testing within the previous 3 years.
• Has undergone a CT colonography in the prior 4 years.
• History of colorectal cancer.
• History of any malignancy within prior 5 years.
• Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).
• 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.
• Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \[HNPCC\], or Familial Adenomatous Polyposis \[FAP\]).
• 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.
• Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
• Known pregnancy at informed consent, blood sample collection, and during study participation.
• 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.

Sponsors & Collaborators

• Universal Diagnostics: lead

Study Sites (1)

Gastroenterology Consultants of SW Virginia

Raonoke, Virginia, 24014, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sample collection.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Kara Mattox

CONTACT

(+1)3392085320; kara.mattox@universaldx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 29, 2023
• Study Start: January 18, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)