NCT06059963Recruiting
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
Source: ClinicalTrials.gov · Last updated 10 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 12000 (estimated)
- First submitted
- 20 Sept 2023
- Start date
- Jan 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- Universal Diagnostics
- Diseases
- Colorectal cancer
- NCT number
- NCT06059963
What you commit to
- Study type: Observational
- Planned participants: 12000
- From Jan 2024 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 any malignancy within prior 5 years.
- 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.
- 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.
Other illness
- History of colorectal cancer.
- Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).
- Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \[HNPCC\], or Familial Adenomatous Polyposis \[FAP\]).
- Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
Age
- 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.
Other
- Undergoing colonoscopy for investigation of CRC risk symptoms
- Has undergone colonoscopy within preceding 9 years
- Known pregnancy at informed consent, blood sample collection, and during study participation.
Who the study is looking for
- 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
Age in the registry: 45 years to 84 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroenterology Consultants of SW Virginia Coordinator of this site? Confirm its status | Raonoke | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.