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

This study has been completed.
Sponsor:
Collaborator:
Early Detection Research Network
Information provided by (Responsible Party):
Missy Tuck, University of Michigan
ClinicalTrials.gov Identifier:
NCT01511653
First received: January 6, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition
Colon Cancer
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Compare biomarkers to colonoscopy as a predictor of CRC risk [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 Two 7 ml purple top (EDTA)tubes 100 ml of urine 2 Fecal Immunohistochemical Tests (FIT)

1 stool bucket


Enrollment: 5230
Study Start Date: October 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Detailed Description:

5.0 STUDY DESIGN 5.1 Subject Recruitment 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, Clinicaltrials.gov) may also be used to recruit subjects from the surrounding communities.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

6000 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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511653

Locations
United States, Illinois
University of Illinois-Chicago
Chicago, Illinois, United States, 60612
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55113
United States, New York
Columbia University
New York, New York, United States, 10032
Mt. Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Michigan
Early Detection Research Network
  More Information

No publications provided

Responsible Party: Missy Tuck, Project Manager, Clinical Research, University of Michigan
ClinicalTrials.gov Identifier: NCT01511653     History of Changes
Obsolete Identifiers: NCT01585363
Other Study ID Numbers: GLNE010
Study First Received: January 6, 2012
Last Updated: June 24, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 19, 2014