Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT04136002
Eligibility Criteria:
Inclusion Criteria:
1. Subjects aged 45-84 years at time of consent
2. Intended to undergo screening colonoscopy
3. Considered by a physician or healthcare provider as being of 'average risk' for CRC
4. Willing to consent to blood draw pre-bowel preparation administration prior to undergoing colonoscopy within 60 days of the date of the investigational blood draw
5. Willing to consent to follow-up for two years as per protocol
Exclusion Criteria:
1. Undergoing colonoscopy for investigation of symptoms
2. Has undergone colonoscopy within preceding 9 years
3. Positive FIT/FOBT result within the previous 6 months
4. Has completed Cologuard or Epi proColon testing within the previous 3 years
5. History of colorectal cancer
6. History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)
7. Known diagnosis of inflammatory bowel disease
8. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs)
9. Positive family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) 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. 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
84 Years
Study:
NCT04136002
Study Brief:
Protocol Section:
NCT04136002