The investigators are undertaking a multi-center, 6000 subject validation study of several biomarkers for early detection of colon cancer. There are 2 stool based biomarkers (one is a panel) and 1 serum based biomarker being validated in this study. The biomarkers will be compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the current standards for colon cancer screening. This is an NCI-early Detection Research Network funded project. The population targeted for this study are those persons undergoing colonoscopy for screening or routine surveillance. Prior to colonoscopy or even prepping for colonoscopy, subjects will provide blood and stool samples as well as specific data regarding their GI and general medical history and concomitant medications. If subjects are interested in participating, arrangements will be made to see them. The informed consent process will take place, blood will be obtained, data will be obtained, and the stool kit described and given to the subject to take home. Stool samples will be sent back to the University of Michigan from all sites using prepaid UPS mailing labels.
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
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.