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

January 6, 2012
June 24, 2014
October 2011
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01511653 on ClinicalTrials.gov Archive Site
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Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma
Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Probability Sample

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.

  • Colon Cancer
  • Rectal Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5230
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01511653
GLNE010
No
Missy Tuck, University of Michigan
University of Michigan
Early Detection Research Network
Not Provided
University of Michigan
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP