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
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Intending 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 before bowel preparation 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 for investigation of colorectal cancer symptoms
- Had a colonoscopy within the preceding 9 years
- Positive fecal immunochemical test (FIT) or fecal occult blood test (FOBT) result within the previous 12 months (+/- 3 months)
- Completed Cologuard or Epi proColon testing within the previous 3 years
- Underwent CT colonography in the prior 4 years
- History of colorectal cancer
- History of any cancer within the prior 5 years
- Known diagnosis of inflammatory bowel disease, including chronic ulcerative colitis and Crohn's disease
- Positive family history of colorectal cancer defined as a first-degree relative diagnosed before age 60 or more than one first-degree relative diagnosed at any age
- Known hereditary or germline risk of colorectal cancer (e.g., Lynch syndrome, hereditary non-polyposis colorectal cancer, familial adenomatous polyposis)
- Major physical trauma (such as surgery, organ transplant, blood transfusion) within 30 days before consent
- Medical condition that, in the investigator's opinion, precludes enrollment
- Known pregnancy at consent, blood collection, and during study participation
- Participation in a clinical trial with experimental medication within 30 days before consent or through the time of colonoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gastroenterology Consultants of SW Virginia
Raonoke, Virginia, United States, 24014
Actively Recruiting
Research Team
K
Kara Mattox
CONTACT
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
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