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Clinical trialNCT01511653CompletedObservational

Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma

SponsorUniversity of MichiganEnrollment13,000Colon CancerRectal Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • University of Calgary-Colon Cancer Screening Centre

    Calgary, Alberta, Canada

Germany
  • German Cancer Research Center (dkfz)

    Heidelberg, Germany

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2011
Primary completion
30 Apr 2019
Completion
30 Apr 2019
Last update posted
18 Jan 2020
Registered enrollment
13,000
Registry id
NCT01511653
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.