An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now
Status: Completed
Location: See all (39) locations...
Intervention Type: Diagnostic test, Procedure
Study Type: Observational
SUMMARY
The primary objective is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 49
Healthy Volunteers: t
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⁃ Subjects must meet the following criteria to be eligible for the study:
• Subject is at average risk for development of CRC.
• Subject is able and willing to undergo a screening colonoscopy.
• Subject is ≥ 45 and ≤ 49 years of age at the time of enrollment.
• Subject is willing and able to sign informed consent.
• Subject is able and willing to provide stool sample(s) according to written instructions provided.
Locations
United States
Arizona
Mayo Clinic Arizona
Phoenix
California
Ventura County Gastroenterology
Camarillo
Alliance Research Centers
Laguna Hills
Focilmed
Oxnard
Desert Oasis Healthcare Medical Group
Palm Springs
Connecticut
Gastroenterology Associates of Fairfield County
Bridgeport
Yale University Section of Digestive Diseases and Liver Diseases
New Haven
Florida
Precision Clinical Research, LLC
Lauderdale Lakes
Illinois
Northshore University Health System Evanston Hospital
Evanston
DM Clinical Research- Southwest Gastroenterology
Oak Lawn
Indiana
Deaconess Clinic- Mt. Pleasant
Evansville
Indiana University, Eskanazi Hospital
Indianapolis
Deaconess Clinic- Gateway
Newburgh
Kansas
Johnson County ClinTrials, LLC
Lenexa
Louisiana
New Orleans Research Institute
Metairie
Delta Research Partners, LLC
Monroe
Louisiana Research Center
Shreveport
Massachusetts
Commonwealth Clinical Studies
Brockton
Maryland
Investigative Clinical Research
Annapolis
Centennial Medical Group
Elkridge
Capitol Research
Rockville
Minnesota
Mayo Clinic Rochester
Rochester
North Carolina
Asheville Gastroenterology Associates
Asheville
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte
Wilmington Gastroenterology Associates
Wilmington
New York
United Medical Associates
Binghamton
Icahn School of Medicine at Mount Sinai
New York
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Family Practice Center of Wooster, Inc./Clinical Trial Developers
Massillon
Great Lakes Gastroenterology Research, LLC
Mentor
Comprehensive Internal Medicine, Inc.
Wooster
South Carolina
Gastroenterology Associates, PA
Greenville
Tennessee
Gastro One
Germantown
Quality Medical Research, PLLC
Nashville
Texas
Austin Regional Clinic
Austin
DM Clinical Research- PCP for Life
Houston
University of Texas Health Science Center- McGovern Medical School
Houston
Virginia
Virginia Gastroenterology Institute
Suffolk
Wisconsin
Wisconsin Center for Advanced Research
Milwaukee
Time Frame
Start Date: 2018-11-06
Completion Date: 2019-06-18
Participants
Target number of participants: 983
Treatments
Subject aged 45-49 with Average CRC Risk
Subject aged 45-49 with average risk for development of CRC.
Authors
Michael Jardula, Xavier Llor, Robert Hardi, Don Brinberg, Steven Itzkowitz, James Gutmann, Michael Epstein, Joseph Kittinger, Thomas Imperiale, Jerry Stern, Charles Berkelhammer, Dana M Bonezzi, Bradley Scheu, Brooks Cash, William Harlan, Carlos Fierro, Russell Heigh, Pramod Malik, Jason Wilson, John Kisiel, Anurekha Chadha, Suzy Kim, Humberto Aguilar, Najmuddin Karimjee, Frank Eder, Kenneth Deck, Karen Simon, Daniel Geenen, Ziad Younes, Raymond Mason, Strick Woods
Related Therapeutic Areas
Sponsors
Leads: Exact Sciences Corporation