A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval
NCT ID: NCT02419716
Last Updated: 2020-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2404 participants
OBSERVATIONAL
2015-04-30
2020-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Cologuard
Prescription of Cologuard for at-home stool collection
Eligibility Criteria
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Inclusion Criteria
2. Subject is at average risk for development of colorectal cancer
3. Subject is 50 years or older
4. Subject willing and able to sign informed consent.
Exclusion Criteria
2. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
3. Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
4. 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).
5. Subject has a history of colorectal cancer or advanced adenoma.
6. Subject has a history of aerodigestive tract cancer
7. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
8. 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)
9. 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.
10. 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.
50 Years
ALL
Yes
Sponsors
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Exact Sciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Imperiale, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Thomas C Lenzmeier, M.D., P.C
Glendale, Arizona, United States
Central Arizona Medical Associates, PC
Mesa, Arizona, United States
Fiel Family and Sports Medicine
Tempe, Arizona, United States
Cassidy Medical Group/Radiant Research, Inc.
Carlsbad, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
Paragon Rx Clinical
Garden Grove, California, United States
UCLA, Division of Digestive Diseases
Los Angeles, California, United States
FACEY Medical Foundation
Mission Hills, California, United States
John D. Homan, MD
Newport Beach, California, United States
Diverse Research Solutions
Oxnard, California, United States
Ventura County Gastroenterology
Oxnard, California, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Advanced Pain Diagnostics & Solutions
Sacramento, California, United States
Innovative Research of West Florida
Clearwater, Florida, United States
Homestead Medical Research
Homestead, Florida, United States
Health Awareness, Inc
Jupiter, Florida, United States
Precision Clinical Research
Lauderdale Lakes, Florida, United States
Advanced Bioresearch
Miami, Florida, United States
Next Phase Research Alliance
Miami, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Health Awareness, Inc-Port St. Lucie
Port Saint Lucie, Florida, United States
The Kaufmann Clinic, Inc.
Atlanta, Georgia, United States
Advanced Clinical Research
Meridian, Idaho, United States
Pharmakon Inc
Evergreen Park, Illinois, United States
Indiana University, Eskanazi Hospital, Regenstrief Health Center
Indianapolis, Indiana, United States
MedPharmics, LLC
Metairie, Louisiana, United States
Columbia Medical Practice
Columbia, Maryland, United States
Centennial Medical Associates
Elkridge, Maryland, United States
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Nevada Family Care
Henderson, Nevada, United States
United Medical Associates
Binghamton, New York, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Sentral Clinical Research
Cincinnati, Ohio, United States
Comprehensive Internal Medicine, Inc.
Wooster, Ohio, United States
Family Practice Center of Wooster, Inc./Clinical Trial Developers
Wooster, Ohio, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, United States
Austin Regional Clinic
Austin, Texas, United States
PCP for Life (DM Research)
Montgomery, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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Exact Sciences 2014-01
Identifier Type: -
Identifier Source: org_study_id
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