Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: 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
Study ID: NCT03728348
Conditions
Study Description
Brief 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.
Detailed Description: Subjects aged 45-49 at average risk for development of CRC will be enrolled. Subjects will complete the mt-sDNA screening test (Cologuard) followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test (Cologuard) will not be provided to investigators for clinical management of study subjects. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathological review of tissue (if applicable) will remain blinded to the results of the mt-sDNA screening test (Cologuard) result.
Eligibility
Minimum Age: 45 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Mayo Clinic Arizona, Phoenix, Arizona, United States
Ventura County Gastroenterology, Camarillo, California, United States
Alliance Research Centers, Laguna Hills, California, United States
Focilmed, Oxnard, California, United States
Desert Oasis Healthcare Medical Group, Palm Springs, California, United States
Gastroenterology Associates of Fairfield County, Bridgeport, Connecticut, United States
Yale University Section of Digestive Diseases and Liver Diseases, New Haven, Connecticut, United States
Precision Clinical Research, LLC, Lauderdale Lakes, Florida, United States
Northshore University Health System Evanston Hospital, Evanston, Illinois, United States
DM Clinical Research- Southwest Gastroenterology, Oak Lawn, Illinois, United States
Deaconess Clinic- Mt. Pleasant, Evansville, Indiana, United States
Indiana University, Eskanazi Hospital, Indianapolis, Indiana, United States
Deaconess Clinic- Gateway, Newburgh, Indiana, United States
Johnson County ClinTrials, LLC, Lenexa, Kansas, United States
New Orleans Research Institute, Metairie, Louisiana, United States
Delta Research Partners, LLC, Monroe, Louisiana, United States
Louisiana Research Center, Shreveport, Louisiana, United States
Investigative Clinical Research, Annapolis, Maryland, United States
Centennial Medical Group, Elkridge, Maryland, United States
Capitol Research, Rockville, Maryland, United States
Commonwealth Clinical Studies, Brockton, Massachusetts, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
United Medical Associates, Binghamton, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Asheville Gastroenterology Associates, Asheville, North Carolina, United States
Charlotte Gastroenterology & Hepatology, PLLC, Charlotte, North Carolina, United States
Wilmington Gastroenterology Associates, Wilmington, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Family Practice Center of Wooster, Inc./Clinical Trial Developers, Massillon, Ohio, United States
Great Lakes Gastroenterology Research, LLC, Mentor, Ohio, United States
Comprehensive Internal Medicine, Inc., Wooster, Ohio, United States
Gastroenterology Associates, PA, Greenville, South Carolina, United States
Gastro One, Germantown, Tennessee, United States
Quality Medical Research, PLLC, Nashville, Tennessee, United States
Austin Regional Clinic, Austin, Texas, United States
University of Texas Health Science Center- McGovern Medical School, Houston, Texas, United States
DM Clinical Research- PCP for Life, Houston, Texas, United States
Virginia Gastroenterology Institute, Suffolk, Virginia, United States
Wisconsin Center for Advanced Research, Milwaukee, Wisconsin, United States
Contact Details
Name: Thomas Imperiale, MD
Affiliation: Indiana University
Role: PRINCIPAL_INVESTIGATOR
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