A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval
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: 15-001739
NCT ID: NCT02419716
Sponsor Protocol Number: Exact Sciences 2014-01
About this study
The purpose of this study is to assess the impact of repeating Cologuard testing for colon cancer at 3 year intervals in average risk patients.
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:
- Subject has been prescribed Cologuard for colorectal cancer screening
- Subject is at average risk for development of colorectal cancer
- Subject is 50 years or older
- Subject willing and able to sign informed consent
Exclusion Criteria:
- Subject had a colonoscopy in the previous 9 years
- Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous (5) years
- Subject has had a positive fecal occult blood test or FIT within the previous six (6) months
- Subject has any condition that in the opinion of the investigator should preclude participation in the study (e.g., subject not eligible for a diagnostic colonoscopy)
- Subject has a history of colorectal cancer or advanced adenoma
- Subject has a history of aerodigestive tract cancer
- Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
- Subject has had overt rectal bleeding, e.g. hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
- Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer
- Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
- 2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring)
- One first-degree relative with CRC diagnosed before the age of 60
- Subject has a family history of
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP)
- Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
- Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis
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 Seth Sweetser, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available