Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma (GLNE010)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01511653
Recruitment Status : Recruiting
First Posted : January 18, 2012
Last Update Posted : November 30, 2017
Early Detection Research Network
Information provided by (Responsible Party):
Dean Brenner, University of Michigan

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 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.

Condition or disease
Colon Cancer Rectal Cancer

Detailed Description:
The clinical research associate or study nurse (hereafter "CRA") at each clinical site will identify subjects with appointments for screening colonoscopy via IRB-approved HIPAA-compliant site-specific methods (Appendix B-tailored to each site). Recruitment methods could include letters from the primary care physicians and gastroenterologists, direct referrals to the study team by physicians, in-clinic recruitment advertisements, and presentations. Interested subjects will be asked to participate in a baseline visit prior to initiation of colonoscopy preparative procedures, either at the local Center or during a visit to the subject's home by a CRA. Advertisements (e.g., newspapers, AARP Magazine, may also be used to recruit subjects from the surrounding communities.

Study Type : Observational
Estimated Enrollment : 13000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma
Actual Study Start Date : October 2011
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Primary Outcome Measures :
  1. Compare biomarkers to colonoscopy as a predictor of CRC risk [ Time Frame: baseline ]
    To validate various biomarkers (stool, blood, urine, FIT) as predictive tools for assessing risk of CRC. Ultimately, these markers may increasing screening and compliance with screening recommendations of CRC by triaging those at higher risk of CRC by thesenon-invasive markers. Those at higher risk of CRC based on biomarker results would be referred for colonoscopy. The assumption is that compliance with colonoscopy would increase if biomarkers suggested an increased risk.

Biospecimen Retention:   Samples With DNA
Two 10 ml red top (serum) tubes Three 10 ml purple top (EDTA)tubes 25 ml of urine 2 Fecal Immunohistochemical Tests (FIT) Stool

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
13000 asymptomatic subjects aged 50-80 undergoing routine colonoscopic screening for colorectal cancer from community and major medical center outpatient settings across multiple centers and consortia will be recruited.

Inclusion Criteria:

  • Adults 50*+ undergoing a first time colonoscopy for screening -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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01511653

Contact: Missy Tuck, M.S. 734-763-1141

United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Audrey Madigan       AudreyP_Madigan@DFCI.HARVARD.EDU;   
Principal Investigator: Sapna Syngal, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kirk Herman   
Principal Investigator: Elena Stoffel, MD         
Sub-Investigator: Dean Brenner, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55113
Contact: Missy Tuck, M.S.    734-763-1141   
Principal Investigator: Timothy Church, PhD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Holly Cirri   
Principal Investigator: John Baron, M.D.         
United States, Pennsylvania
Penn State College of Medicine Recruiting
Hershey, Pennsylvania, United States
Contact: Jessica Wright   
Contact: Laura Kline   
Principal Investigator: Mack Ruffin, M.D.         
United States, Texas
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Tamara Tipps   
Principal Investigator: Robert Bresalier, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Winn Burke   
Principal Investigator: William Grady, M.D.         
Canada, Alberta
University of Calgary-Colon Cancer Screening Centre Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Susana Town   
Contact: Shane Cartwright   
Principal Investigator: Robert Hilsden, M.D.         
German Cancer Research Center (DKFZ) Recruiting
Heidelberg, Germany, 69120
Contact: Kaja Tikk, Ph.D.   
Principal Investigator: Hermann Brenner, M.D.         
Sponsors and Collaborators
University of Michigan
Early Detection Research Network

Responsible Party: Dean Brenner, Professor Internal Medicine, University of Michigan Identifier: NCT01511653     History of Changes
Obsolete Identifiers: NCT01585363
Other Study ID Numbers: GLNE010
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dean Brenner, University of Michigan:
screening colonoscopy
colon cancer early detection
rectal cancer early detection
colorectal cancer prevention
biomarker validation

Additional relevant MeSH terms:
Rectal Neoplasms
Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases