Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
- Conditions
- Colorectal Cancer
- Interventions
- Diagnostic Test: mt-sDNA 2.0 screening testDiagnostic Test: FIT testProcedure: Colonoscopy
- Registration Number
- NCT04144738
- Lead Sponsor
- Exact Sciences Corporation
- Brief Summary
The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.
- Detailed Description
Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subject will complete the mt-sDNA 2.0 test and the commercially available FIT, followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test and FIT will not be provided to investigators for clinical management of the study subject. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathologial review of reports or tissue (if applicable) will remain blinded to the results of the mt-sDNA 2.0 screening test results.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26758
Subjects must meet the following criteria to be eligible for the study:
- Subject is ≥ 40 years of age at the time of enrollment.
- Subject presents for a screening colonoscopy per standard of care.
- Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
- Subject is able and willing to sign informed consent
-
Subject has a history of CRC or advanced precancerous lesions.
-
Subject has a diagnosis or medical / family history of any of the following conditions, including:
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
- Hereditary non-polyposis CRC 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), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
-
Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
-
Subject has a diagnosis of Cronkhite-Canada Syndrome.
-
Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
-
Subject has undergone a colonoscopy within the previous 9 years with the exception of a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
-
Subject has had overt rectal bleeding within the previous 30 days.
-
Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Individuals eligible for CRC Screening FIT test Individuals who are 40 years of age and older, eligible for CRC screening, and scheduled for a screening colonoscopy. Individuals eligible for CRC Screening Colonoscopy Individuals who are 40 years of age and older, eligible for CRC screening, and scheduled for a screening colonoscopy. Individuals eligible for CRC Screening mt-sDNA 2.0 screening test Individuals who are 40 years of age and older, eligible for CRC screening, and scheduled for a screening colonoscopy.
- Primary Outcome Measures
Name Time Method Specificity with the mt-sDNA 2.0 test Through study completion, an average of 180 days Sensitivity for CRC with the mt-sDNA 2.0 test Through study completion, an average of 180 days
- Secondary Outcome Measures
Name Time Method Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT). Through study completion, an average of 180 days Sensitivity for advanced precancerous lesions Through study completion, an average of 180 days Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT) Through study completion, an average of 180 days Specificity for no colorectal neoplastic findings Through study completion, an average of 180 days
Trial Locations
- Locations (187)
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Tri-Cities
🇺🇸Kingsport, Tennessee, United States
Alliance for Multispecialty Research, LLC
🇺🇸Norman, Oklahoma, United States
Mercy Family Clinic
🇺🇸Dallas, Texas, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Richard L. Roudebush VA Medical Center
🇺🇸Indianapolis, Indiana, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Houston Digestive Disease
🇺🇸Houston, Texas, United States
Fairway Medical Clinic
🇺🇸Houston, Texas, United States
UT MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Benaroya Research Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
SDG Clinical Research
🇺🇸San Diego, California, United States
Research Associates of South Florida, LLC
🇺🇸Miami, Florida, United States
University of Nevada, Las Vegas
🇺🇸Las Vegas, Nevada, United States
Hightop Medical Research Clinic
🇺🇸Cincinnati, Ohio, United States
Gastroenterology Research of San Antonio
🇺🇸San Antonio, Texas, United States
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
Alternative Solutions, LLC
🇺🇸Saint Petersburg, Florida, United States
Desert Oasis Healthcare Medical Group
🇺🇸Palm Springs, California, United States
Westside Center of Clinical Research
🇺🇸Jacksonville, Florida, United States
Atlanta Center for Gastroenterology, P.C.
🇺🇸Decatur, Georgia, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Facey Medical Foundation
🇺🇸Mission Hills, California, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Knowledge Research Center
🇺🇸Orange, California, United States
Fomat Medical Research
🇺🇸Camarillo, California, United States
East View Medical Research, LLC
🇺🇸Mobile, Alabama, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Palo Alto Veterans Institute for Research
🇺🇸Palo Alto, California, United States
Alliance Research Institute
🇺🇸Canoga Park, California, United States
Margaret Mary Health
🇺🇸Batesville, Indiana, United States
United Medical Doctors
🇺🇸Irvine, California, United States
G & L Research
🇺🇸Foley, Alabama, United States
GI Associates of West Alabama, P.C
🇺🇸Tuscaloosa, Alabama, United States
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
Gastro Care Institute
🇺🇸Lancaster, California, United States
GW Research Inc
🇺🇸Chula Vista, California, United States
Prime Care Clinical Research Center
🇺🇸Laguna Hills, California, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Southern Arizona VA Health Care System (SAVAHCS)
🇺🇸Tucson, Arizona, United States
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
Arkansas Gastroenterology, P.A.
🇺🇸North Little Rock, Arkansas, United States
Paragon Rx Clinical, Inc.
🇺🇸Garden Grove, California, United States
Connecticut Clinical Research Institute
🇺🇸Bristol, Connecticut, United States
Vanguard Clinical Research
🇺🇸Fort Myers, Florida, United States
Unison Clinical Trials
🇺🇸Sherman Oaks, California, United States
GI Partners of IL / Avicenna
🇺🇸Downers Grove, Illinois, United States
Edward Hines Jr. VA Hospital
🇺🇸Hines, Illinois, United States
Paragon Rx Clinical, Inc. - Santa Ana
🇺🇸Santa Ana, California, United States
Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Massachusetts - Worcester
🇺🇸Worcester, Massachusetts, United States
Shands Jacksonville Medical Center, Inc - University of Florida Health
🇺🇸Jacksonville, Florida, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
San Jose Gastroenterology
🇺🇸San Jose, California, United States
Pioneer Clinical Research
🇺🇸Lighthouse Point, Florida, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
Christie Clinic, LLC
🇺🇸Champaign, Illinois, United States
PMG Research
🇺🇸Ames, Iowa, United States
Combined Gastro Research, LLC
🇺🇸Lafayette, Louisiana, United States
Gastroenterology Associates of Fairfield County
🇺🇸Bridgeport, Connecticut, United States
Next Phase Research Alliance
🇺🇸Miami, Florida, United States
Louisiana Research Center; Gastrointestinal Associates
🇺🇸Shreveport, Louisiana, United States
Gastro Health Research
🇺🇸Cincinnati, Ohio, United States
New West Physicians
🇺🇸Golden, Colorado, United States
Millennium Clinical Trials
🇺🇸Thousand Oaks, California, United States
Augusta University
🇺🇸Augusta, Georgia, United States
The South Bend Clinic
🇺🇸South Bend, Indiana, United States
Dream Team Clinical Research
🇺🇸Upland, California, United States
Cornerstone Research Institute
🇺🇸Altamonte Springs, Florida, United States
Sarkis Clinical Trials
🇺🇸Ocala, Florida, United States
Grand Teton Research Group
🇺🇸Idaho Falls, Idaho, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Methodist Physicians Clinic / CCT Research
🇺🇸Fremont, Nebraska, United States
The Iowa Clinic, P.C.
🇺🇸West Des Moines, Iowa, United States
St. Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
Horizon Research Group of Opelousas, LLC
🇺🇸Eunice, Louisiana, United States
Clinical Trials Management, LLC
🇺🇸Metairie, Louisiana, United States
NECCR PrimaCare Research, LLC
🇺🇸Fall River, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Beth Israel Deaconess Medical Center - Harvard
🇺🇸Boston, Massachusetts, United States
AGA Clinical Research Associates, LLC
🇺🇸Egg Harbor Township, New Jersey, United States
Sing Chan, MD
🇺🇸Flushing, New York, United States
Ascension Via Christi Hospitals Wichita, Inc
🇺🇸Wichita, Kansas, United States
Deaconess Clinic, Inc.
🇺🇸Newburgh, Indiana, United States
Clinical Trials of SWLA, LLC
🇺🇸Lake Charles, Louisiana, United States
IQVIA RDS, Inc.
🇺🇸Cambridge, Massachusetts, United States
Oakland Medical Research
🇺🇸Troy, Michigan, United States
DiGiovanna Institute for Medical Education & Research
🇺🇸North Massapequa, New York, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
Houma Digestive Health Specialists-CroNOLA
🇺🇸Houma, Louisiana, United States
Southern Therapy and Advanced Research LLC (STAR)
🇺🇸Jackson, Mississippi, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Troy, Michigan, United States
Digestive Health Center of the Four States, LLC
🇺🇸Galena, Kansas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
WR-ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Digestive Health Specialists, PC
🇺🇸Chelmsford, Massachusetts, United States
United Health Services Hospitals, Inc.
🇺🇸Binghamton, New York, United States
Coastal Research Institute, LLC
🇺🇸Fayetteville, North Carolina, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Comprehensive Internal Medicine, Inc
🇺🇸Wooster, Ohio, United States
Dayton Clinical Resesarch
🇺🇸Dayton, Ohio, United States
Mid Hudson Medical Research, PLLC
🇺🇸New Windsor, New York, United States
Digestive Health Associates
🇺🇸Reno, Nevada, United States
Coastal Carolina Health Care, P.A.
🇺🇸New Bern, North Carolina, United States
Plains Clinical Research Center, LLC
🇺🇸Fargo, North Dakota, United States
Paramount Medical Research and Consulting, LLC
🇺🇸Middleburg Heights, Ohio, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Atrium Health Department of Family Medicine Research
🇺🇸Charlotte, North Carolina, United States
Javara
🇺🇸Charlotte, North Carolina, United States
Allied Health Clinical Research Organization, LLC
🇺🇸West Long Branch, New Jersey, United States
Trial Management Associates, LLC
🇺🇸Wilmington, North Carolina, United States
Lillestol Research, LLC
🇺🇸Fargo, North Dakota, United States
Regional GI
🇺🇸Lancaster, Pennsylvania, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Granger Medical Clinic
🇺🇸Riverton, Utah, United States
University Physicians and Surgeons, Inc. DBA Marshall Health
🇺🇸Huntington, West Virginia, United States
Medication Management LLC
🇺🇸Greensboro, North Carolina, United States
Great Lakes Medical Research, LLC
🇺🇸Union City, Tennessee, United States
Northshore Gastroenterology Research, LLC
🇺🇸Westlake, Ohio, United States
Great Lakes Gastroenterology Research, LLC
🇺🇸Mentor, Ohio, United States
VA NY Harbor HCS- Brooklyn Campus
🇺🇸Brooklyn, New York, United States
Digestive Health Partners, PA
🇺🇸Asheville, North Carolina, United States
ARC Clinical Research at Kelly Lane
🇺🇸Pflugerville, Texas, United States
Options Health Research, LLC
🇺🇸Tulsa, Oklahoma, United States
META Medical Research Institute, LLC
🇺🇸Dayton, Ohio, United States
Richard M. Kastelic, M.D., and Associates, P.C.
🇺🇸Johnstown, Pennsylvania, United States
Wellness Clinical Research
🇺🇸McKinney, Texas, United States
Digestive System Healthcare
🇺🇸Houston, Texas, United States
Clinical Associates in Research Therapeutics of America
🇺🇸San Antonio, Texas, United States
Spokane Gastroenterology
🇺🇸Spokane, Washington, United States
Care Access Research, Pottsville
🇺🇸Pottsville, Pennsylvania, United States
Advanced Research Institute
🇺🇸Sandy, Utah, United States
Blue Ridge Medical Research
🇺🇸Lynchburg, Virginia, United States
Texas Gastro Consultants
🇺🇸Tomball, Texas, United States
Wenatchee Valley Hospital
🇺🇸Wenatchee, Washington, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
The Jackson Clinic, PA
🇺🇸Jackson, Tennessee, United States
Texas Tech University Health Sciences Center El Paso
🇺🇸El Paso, Texas, United States
Epic Medical Research, LLC
🇺🇸Red Oak, Texas, United States
Virginia Gastroenterology Institute
🇺🇸Suffolk, Virginia, United States
Dharma PA D/B/A Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
FMC Science, LLC
🇺🇸Lampasas, Texas, United States
Rio Grande Gastroenterology
🇺🇸McAllen, Texas, United States
Progressive Clinical Research, LLC
🇺🇸Bountiful, Utah, United States
Advanced Clinical Research
🇺🇸Riverton, Utah, United States
Summit Clinical Research
🇺🇸Petersburg, Virginia, United States
Mayo Clinic - AZ
🇺🇸Phoenix, Arizona, United States
SSM Health Medical Group/Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Summit Internal Medicine, PC
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
CHI Nebraska
🇺🇸Omaha, Nebraska, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Ascension Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Clinical Trials of Tampa
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
SIMED Health Research
🇺🇸Gainesville, Florida, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Ralph H. Johnson VAMC
🇺🇸Charleston, South Carolina, United States
Pharmacorp Clinical Trials, Inc.
🇺🇸Charleston, South Carolina, United States
ARC Clinical Research at William Cannon
🇺🇸Austin, Texas, United States
ARC Clinical Research at Four Points
🇺🇸Austin, Texas, United States
Elligo Health Research Inc.
🇺🇸Austin, Texas, United States
Avant Research Associates
🇺🇸Austin, Texas, United States
Central Virginia VA Healthcare System
🇺🇸Richmond, Virginia, United States
Delta Research Partners
🇺🇸Monroe, Louisiana, United States
Clinical Trials of America, LLC
🇺🇸Mount Airy, North Carolina, United States
Imic, Inc.
🇺🇸Palmetto Bay, Florida, United States
Precision Clinical Research, LLC
🇺🇸Sunrise, Florida, United States
Hutchinson Clinic
🇺🇸Hutchinson, Kansas, United States
Wr-Msra, Llc
🇺🇸Lake City, Florida, United States
Family Medical Specialists of Florida, PLC
🇺🇸Plant City, Florida, United States
Infinite Clinical Trials
🇺🇸Morrow, Georgia, United States
Summit Clinical Research, LLC
🇺🇸Athens, Georgia, United States
New Orleans Research Institute
🇺🇸Metairie, Louisiana, United States
Rapid City Medical Center, LLP
🇺🇸Rapid City, South Dakota, United States
Clinical Research Solutions, LLC - TN
🇺🇸Jackson, Tennessee, United States
Invocare Medical Research & Healthcare Center
🇺🇸West Columbia, South Carolina, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States