Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma

Completed

Conditions studied: Colon Cancer, Rectal Cancer

In brief

The investigators are undertaking a multi-center, 13000 subject validation study of several biomarkers for early detection of colon cancer. There are stool based biomarkers and blood based biomarkers 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. 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 using prepaid mailing labels.

Key facts

Study ID

NCT01511653

Run by

University of Michigan

People needed

13000

Starts

2011-10-01

Expected to finish

2019-04-01

Last updated by the study team

2020-01-18

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults 40*+ undergoing a first time colonoscopy for screening OR
• Positive guaiac-based occult blood or fecal immunochemical test (e.g. FOBT, FIT) in the past 12 months (365 days)
• Willing to sign informed consent
• Able to physically tolerate removal of 50 ml of blood
• Willing to collect 2 stool samples
• (*age 60 and up in U.S., 50 and up outside US)

You may not qualify if…

• Inability to provide informed consent
• History of Inflammatory Bowel Disease
• Overt rectal bleeding within 1 month (30 days) (including due to suspected hemorrhoids)
• 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

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Penn State College of Medicine — Hershey, Pennsylvania, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States
• University of Calgary-Colon Cancer Screening Centre — Calgary, Alberta, Canada
• German Cancer Research Center (DKFZ) — Heidelberg, Germany

Full record on ClinicalTrials.gov

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