Collection of Samples USOPTIVAL Study

Prior treatment

• Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer.
• The patient has a known or documented previous or current medical history of infectious diseases that can be transmitted through blood (E.g. Hepatitis, HIV, etc.), including patients that have been treated, are currently being treated, or have not been treated for that conditions.

Other illness

• Subject has a current diagnosis of cancer.
  • Arms A \& B:
• Subject has a personal history of aerodigestive or digestive tract cancers.
• A significant disease which, in the Investigator's opinion, would exclude the subject from the study.
• Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent.

Age

• Has a known diagnosis or personal history of any of the following high-risk indications for colorectal cancer:
  • Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
  • Familial adenomatous polyposis ("FAP", including attenuated FAP).
  • Hereditary non-polyposis colorectal cancer syndrome ("HNPCC" or "Lynch Syndrome").
  • Serrated polyposis syndrome
  • 2 first-degree relatives (e.g., parents, siblings, and offspring) who have been diagnosed with colon cancer.
  • One first-degree relative with CRC diagnosed before the age of 60.

Other

• Arm A Only:
• 1\. Subject with curative biopsy during colonoscopy.
• Arm B Only:
• Subjects with positive FIT Test results in the 6 months preceding enrollment.
• Legal incapacity or limited mental capacity.
• The patient is known to be pregnant when recruited or during her participation in the study.

• Arm A:
• Must be 45-84 years of age.
• Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery.
• Able to comprehend, sign, and date the written informed consent document.
  • Arm B:
• Must be 45-84 years of age.
• Able and willing to undergo a standard-of-care screening colonoscopy within 60 days.
• Able to comprehend, sign, and date the written informed consent document.