A Study of Cologuardâ„¢ in an Average Risk Population Assessing a Three Year Test Interval
- Conditions
- Colorectal CancerColorectal Cancer Screening
- Registration Number
- NCT02419716
- Lead Sponsor
- Exact Sciences Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2404
- 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.
-
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 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Positive and Negative Predictive Value 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 Outcome Measures
Name Time Method Colorectal Cancer Incidence 3 years Observed versus the expected reduction in colorectal cancer incidence at year 3 (T3)
Trial Locations
- Locations (40)
UCLA, Division of Digestive Diseases
🇺🇸Los Angeles, California, United States
John D. Homan, MD
🇺🇸Newport Beach, California, United States
Nevada Family Care
🇺🇸Henderson, Nevada, United States
Columbia Medical Practice
🇺🇸Columbia, Maryland, United States
Central Arizona Medical Associates, PC
🇺🇸Mesa, Arizona, United States
Thomas C Lenzmeier, M.D., P.C
🇺🇸Glendale, Arizona, United States
Health Awareness, Inc
🇺🇸Jupiter, Florida, United States
FACEY Medical Foundation
🇺🇸Mission Hills, California, United States
Diverse Research Solutions
🇺🇸Oxnard, California, United States
Fiel Family and Sports Medicine
🇺🇸Tempe, Arizona, United States
Cassidy Medical Group/Radiant Research, Inc.
🇺🇸Carlsbad, California, United States
Paragon Rx Clinical
🇺🇸Garden Grove, California, United States
Kindred Medical Institute for Clinical Trials, LLC
🇺🇸Corona, California, United States
Precision Clinical Research
🇺🇸Lauderdale Lakes, Florida, United States
Ventura County Gastroenterology
🇺🇸Oxnard, California, United States
Homestead Medical Research
🇺🇸Homestead, Florida, United States
Desert Oasis Healthcare Medical Group
🇺🇸Palm Springs, California, United States
Innovative Research of West Florida
🇺🇸Clearwater, Florida, United States
Advanced Clinical Research
🇺🇸Meridian, Idaho, United States
MedPharmics, LLC
🇺🇸Metairie, Louisiana, United States
The Kaufmann Clinic, Inc.
🇺🇸Atlanta, Georgia, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
Health Awareness, Inc-Port St. Lucie
🇺🇸Port Saint Lucie, Florida, United States
Pharmakon Inc
🇺🇸Evergreen Park, Illinois, United States
Centennial Medical Associates
🇺🇸Elkridge, Maryland, United States
United Medical Associates
🇺🇸Binghamton, New York, United States
PCP for Life (DM Research)
🇺🇸Montgomery, Texas, United States
Regional Clinical Research, Inc.
🇺🇸Endwell, New York, United States
University of North Carolina, Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Internal Medicine, Inc.
🇺🇸Wooster, Ohio, United States
Harleysville Medical Associates
🇺🇸Harleysville, Pennsylvania, United States
Austin Regional Clinic
🇺🇸Austin, Texas, United States
Family Practice Center of Wooster, Inc./Clinical Trial Developers
🇺🇸Wooster, Ohio, United States
Advanced Bioresearch
🇺🇸Miami, Florida, United States
Next Phase Research Alliance
🇺🇸Miami, Florida, United States
Indiana University, Eskanazi Hospital, Regenstrief Health Center
🇺🇸Indianapolis, Indiana, United States
Sentral Clinical Research
🇺🇸Cincinnati, Ohio, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Mayo Clinic Minnesota
🇺🇸Rochester, Minnesota, United States
Advanced Pain Diagnostics & Solutions
🇺🇸Sacramento, California, United States