A Study to Follow-up on Patients Involved in the Cologuard Stool DNA Testing Studies for Colorectal Cancer

Overview

About this study

The purpose of this study is to assess the long term clinical outcomes of patients who had a false positive stool DNA test for colorectal cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Were in the “DEEP-C” study [#11-005474, 11-005737, 12-000184], “MUST-FIT” study [#10-004833], and the “Specificity” study [#09-007817] from Mayo Clinic sites in Minnesota, Arizona and Florida
  • Are asymptomatic
  • Were average-risk for colorectal cancer and aged between 50 and 84 at the time of initial stool test and colonoscopy
  • Have consented to be contacted for future studies

 

Exclusion Criteria

  • Not of average-risk for colorectal cancer as specified in the individual protocols 
  • Were outside the age range of 50-84 at the time of initial testing
  • Have characteristics which place them at an increased risk of colorectal cancer
    • Personal history of colorectal neoplasia, digestive cancer, or inflammatory bowel disease
    • Family history of colorectal cancer
    • Positive results on fecal blood testing within the previous 6 months
    • Overt rectal bleeding

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

John Kisiel, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20301158

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