A Longitudinal Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Exact Sciences Corporation
- Enrollment
- 2,404
- Locations
- 40
- Primary Endpoint
- Positive and Negative Predictive Value
Study Overview
Brief Summary
This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients.
Detailed Description
This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients. Enrolled subjects will be prescribed Cologuard per approved labeling at baseline. Subjects with positive results will be referred to colonoscopy and study participation completed. Subjects with negative Cologuard results will be seen annually for 3 years. At year 3, subjects will repeat Cologuard, followed by colonoscopy, regardless of the Cologuard test outcome. Subjects who have a colonoscopy at any time during the study will be discontinued following collection of the colonoscopy and associated histopathology results.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 five (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
- •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.
Outcomes
Primary Outcomes
Positive and Negative Predictive Value
Time Frame: Three years
The difference between the positive predictive value (PPV) at year 3 (PPV3) and 1 minus the negative predictive value (NPV) at year 3 (NPV3).
Secondary Outcomes
- Colorectal Cancer Incidence(3 years)