Status:
COMPLETED
Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Early Detection Research Network
Conditions:
Colon Cancer
Rectal Cancer
Eligibility:
All Genders
40+ years
Brief Summary
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 ...
Detailed Description
The goal of this trial is to estimate the sensitivity and specificity of stool vimentin methylation, serum galectin-3 ligand, and fecal immunochemical testing for colorectal adenocarcinoma, or 2) scre...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
13000 Patients enrolled
Trial Details
Trial ID
NCT01511653
Start Date
October 1 2011
End Date
April 1 2019
Last Update
January 18 2020
Active Locations (9)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
University of Minnesota
Minneapolis, Minnesota, United States, 55113
4
University of North Carolina
Chapel Hill, North Carolina, United States, 27599