Actively Recruiting
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
Led by Universal Diagnostics · Updated on 2025-11-10
12000
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance of Signal-C14, a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions in people aged 45 and older who are at average risk. This observational study aims to assess how well this test works in identifying these conditions in a typical screening population. Participants in this study are patients aged 45 to 84 who are scheduled for a standard screening colonoscopy and considered at average risk for colorectal cancer. Signal-C14 uses a blood sample collected via venipuncture to analyze circulating cell-free DNA with advanced sequencing and machine learning techniques. The study involves collecting blood before bowel preparation or colonoscopy, ideally within 90 days of the blood draw. During the study, participants will provide blood samples and undergo their planned colonoscopy. Researchers will follow participants for one year to monitor outcomes and evaluate the test's performance. The primary outcome will be assessed within one year, and follow-up includes monitoring for colorectal cancer detection and advanced lesions. Participants must consent to the procedures and follow-up as outlined in the protocol.
CONDITIONS
Brief Title
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 colorectal cancer
- Willing to consent to blood draw prior to bowel preparatory procedures or colonoscopy, ideally within 90 days of blood draw
- Willing to consent to follow-up for one year as per protocol
- Able and willing to sign informed consent
You will not qualify if you...
- Undergoing colonoscopy due to symptoms suggesting colorectal cancer risk
- Had a colonoscopy within the past 9 years
- Positive fecal immunochemical test or fecal occult blood test in the past 12 months (plus or minus 3 months)
- Completed Cologuard or Epi proColon testing within the past 3 years
- Had a CT colonography within the past 4 years
- History of colorectal cancer
- History of any cancer within the past 5 years
- Diagnosed with inflammatory bowel disease, including chronic ulcerative colitis or Crohn's disease
- Positive family history of colorectal cancer with first-degree relative diagnosed before age 60 or with more than one first-degree relative affected
- Known hereditary colorectal cancer risk such as Lynch syndrome or Familial Adenomatous Polyposis
- Major physical trauma such as surgery, organ transplant, or blood transfusion within 30 days before consent
- Any medical condition that would prevent study enrollment as determined by the investigator
- Known pregnancy at consent, blood collection, or during study participation
- Participation in a clinical trial involving experimental medication within 30 days before consent or through colonoscopy date
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for blood draw prior to colonoscopy
Duration - Day of colonoscopy
Participants undergo a standard-of-care screening colonoscopy as part of routine healthcare.
1 visit (in-person) for colonoscopy procedure
Duration - 1 year
Participants are followed for one year after the colonoscopy to collect outcome data and observe health status.
Follow-up contacts as per study protocol
Trial Site Locations
Total: 1 location
1
Gastroenterology Consultants of SW Virginia
Raonoke, Virginia, United States, 24014
Actively Recruiting
Research Team
K
Kara Mattox
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here