Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma

Inclusion Criteria:

- Adults 50-80 and undergoing a colonoscopy defined as:

- First time screening or a surveillance procedure

- No complete colon exam (colonoscopy or CT colonography) within 3 years except
as noted. (see section 5.4.1)

- Willing to sign informed consent

- Able to physically tolerate removal of 34ml of blood

- Willing to collect 2 stool samples

Exclusion Criteria:

- Inability to provide informed consent

- History of Inflammatory Bowel Disease

- Overt rectal bleeding within 1 month (30 days) (including due to suspected
hemorrhoids)

- Positive guaiac-based occult blood or fecal immunochemical test (e.g. FOBT, FIT) in
the past 12 months (365 days)

- Undergone resection of the colon for any indication

- Subjects with known HIV or chronic viral hepatitis (Hepatitis B and C)

- Subjects with known or suspected HNPCC (Lynch Syndrome) or FAP

- Any cancer within 5 years of enrollment except any of the following:

- Squamous cell carcinoma of the skin or Basal cell carcinoma of the skin

- Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell
carcinoma of the cervix treated by surgery only. (Excluded if had pelvic
radiation)

- Stage , 0, I or Ia Grade 1 adenocarcinoma of the endometrium treated with
surgery