Clinical Trials

Inclusion Criteria:

• Subject has been prescribed Cologuard for colorectal cancer screening
• Subject is at average risk for development of colorectal cancer
• Subject is 50 years or older
• Subject willing and able to sign informed consent

Exclusion Criteria:

• Subject had a colonoscopy in the previous 9 years
• Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous (5) years
• Subject has had a positive fecal occult blood test or FIT within the previous six (6) months
• 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)
• Subject has a history of colorectal cancer or advanced adenoma
• Subject has a history of aerodigestive tract cancer
• Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
• 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)
• 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
• 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