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:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT02419716
Eligibility Criteria:
Inclusion Criteria:
1. Subject has been prescribed Cologuard for colorectal cancer screening
2. Subject is at average risk for development of colorectal cancer
3. Subject is 50 years or older
4. Subject willing and able to sign informed consent.
Exclusion Criteria:
1. Subject had a colonoscopy in the previous 9 years
2. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
3. Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
4. Subject has any condition that in the opinion of the investigator should preclude participation in the study (e.g., subject not eligible for a diagnostic colonoscopy).
5. Subject has a history of colorectal cancer or advanced adenoma.
6. Subject has a history of aerodigestive tract cancer
7. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
8. Subject has had overt rectal bleeding, e.g. hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
9. Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
* Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
* 2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
* One first-degree relative with CRC diagnosed before the age of 60.
10. Subject has a family history of:
* Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
* Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
* Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02419716
Study Brief:
Protocol Section:
NCT02419716