Recruiting

Observational Study

Sponsor:

Universal Diagnostics

Code:

NCT06059963

Conditions

Colorectal Cancer

Advanced Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Signal-C™

Study Details

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

Study ID

NCT06059963

Start date

Jan 18, 2024

Status verified date

Nov, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

12000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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).

Primary outcome measure

  • Primary Objective [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Gastroenterology Consultants of SW Virginia

Recruiting

Raonoke, Virginia, United States, 24014

More Information

Sponsor

Universal Diagnostics

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • Advanced Precancerous Lesions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Universal Diagnostics on 2025-11-10.