Evaluating a blood test for detecting colorectal cancer and precancerous lesions

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

This study is testing a blood test to see if it can help find colorectal cancer and serious precancerous growths in people aged 45 and older who are at average risk.

Quick facts

• Study type: Observational
• Enrollment: 12000 (estimated)
• Ages: 45 Years to 84 Years
• Sex: All
• Sponsor: Universal Diagnostics (Industry-sponsored)
• Locations: 1 site (Raonoke, Virginia)
• Trial ID: NCT06059963 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the performance of the Signal-C™ plasma circulating free-DNA test in detecting colorectal cancer and advanced precancerous lesions in individuals aged 45 and older who are considered at average risk. Participants will undergo a standard screening colonoscopy and provide a blood sample prior to the procedure. The study will follow participants for one year to gather data on the test's effectiveness. The goal is to improve early detection methods for colorectal cancer.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 45-84 who are at average risk for colorectal cancer and are scheduled for a standard screening colonoscopy.

Not a fit: Patients who have a history of colorectal cancer or other malignancies, or those undergoing colonoscopy for symptoms related to CRC risk, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and non-invasive screening methods for colorectal cancer, potentially improving early detection and patient outcomes.

How similar studies have performed: Other studies evaluating similar blood-based tests for colorectal cancer detection have shown promising results, indicating potential for this approach.

Eligibility criteria

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.

Where this trial is running

Raonoke, Virginia

• Gastroenterology Consultants of SW Virginia — Raonoke, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Kara Mattox

Conditions Colorectal Cancer; Advanced Adenocarcinoma; Advanced Precancerous Lesions