A Study to Follow-up on Patients Involved in the Cologuard Stool DNA Testing Studies for Colorectal Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-009014
Sponsor Protocol Number: 14-009014
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