Status:
RECRUITING
A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
Lead Sponsor:
Universal Diagnostics
Conditions:
Colorectal Cancer
Advanced Adenocarcinoma
Eligibility:
All Genders
45-84 years
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Undergoing colonoscopy for investigation of CRC risk symptoms
- Has undergone colonoscopy within preceding 9 years
- 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 colorectal cancer.
- History of any malignancy within prior 5 years.
- Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).
- 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.
- Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \[HNPCC\], or Familial Adenomatous Polyposis \[FAP\]).
- 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.
- Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
- Known pregnancy at informed consent, blood sample collection, and during study participation.
- 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.
Key Trial Info
Start Date :
January 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
12000 Patients enrolled
Trial Details
Trial ID
NCT06059963
Start Date
January 18 2024
End Date
December 1 2026
Last Update
November 7 2025
Active Locations (1)
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1
Gastroenterology Consultants of SW Virginia
Raonoke, Virginia, United States, 24014