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Spots Global Cancer Trial Database for Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

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Trial Identification

Brief Title: Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

Official Title: Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

Study ID: NCT04144738

Study Description

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.

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Parkway Medical Center, Birmingham, Alabama, United States

Summit Internal Medicine, PC, Birmingham, Alabama, United States

University of Alabama at Birmingham, Birmingham, Alabama, United States

Cullman Clinical Trials, Cullman, Alabama, United States

Digestive Health Specialists of the Southeast, Dothan, Alabama, United States

G & L Research, Foley, Alabama, United States

Medical Affiliated Research Center, Huntsville, Alabama, United States

East View Medical Research, LLC, Mobile, Alabama, United States

GI Associates of West Alabama, P.C, Tuscaloosa, Alabama, United States

Mayo Clinic - AZ, Phoenix, Arizona, United States

Del Sol Research Management, LLC, Tucson, Arizona, United States

Southern Arizona VA Health Care System (SAVAHCS), Tucson, Arizona, United States

Lynn Institute of the Ozarks, Little Rock, Arkansas, United States

Applied Research Center of Arkansas, Little Rock, Arkansas, United States

Arkansas Gastroenterology, P.A., North Little Rock, Arkansas, United States

Fomat Medical Research, Camarillo, California, United States

Alliance Research Institute, Canoga Park, California, United States

GW Research Inc, Chula Vista, California, United States

Paragon Rx Clinical, Inc., Garden Grove, California, United States

United Medical Doctors, Irvine, California, United States

Prime Care Clinical Research Center, Laguna Hills, California, United States

Gastro Care Institute, Lancaster, California, United States

Facey Medical Foundation, Mission Hills, California, United States

Knowledge Research Center, Orange, California, United States

Desert Oasis Healthcare Medical Group, Palm Springs, California, United States

Palo Alto Veterans Institute for Research, Palo Alto, California, United States

SDG Clinical Research, San Diego, California, United States

San Jose Gastroenterology, San Jose, California, United States

Paragon Rx Clinical, Inc. - Santa Ana, Santa Ana, California, United States

Sansum Clinic, Santa Barbara, California, United States

Unison Clinical Trials, Sherman Oaks, California, United States

Millennium Clinical Trials, Thousand Oaks, California, United States

Dream Team Clinical Research, Upland, California, United States

New West Physicians, Golden, Colorado, United States

Gastroenterology Associates of Fairfield County, Bridgeport, Connecticut, United States

Bridgeport Hospital, Bridgeport, Connecticut, United States

Connecticut Clinical Research Institute, Bristol, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Cornerstone Research Institute, Altamonte Springs, Florida, United States

Vanguard Clinical Research, Fort Myers, Florida, United States

SIMED Health Research, Gainesville, Florida, United States

Westside Center of Clinical Research, Jacksonville, Florida, United States

Shands Jacksonville Medical Center, Inc - University of Florida Health, Jacksonville, Florida, United States

Health Awareness, Inc., Jupiter, Florida, United States

Wr-Msra, Llc, Lake City, Florida, United States

Pioneer Clinical Research, Lighthouse Point, Florida, United States

Suncoast Research Group, LLC, Miami, Florida, United States

Next Phase Research Alliance, Miami, Florida, United States

Research Associates of South Florida, LLC, Miami, Florida, United States

Gastro Health Research, Miami, Florida, United States

Gastroenterology Group of Naples, Naples, Florida, United States

Sarkis Clinical Trials, Ocala, Florida, United States

Imic, Inc., Palmetto Bay, Florida, United States

Family Medical Specialists of Florida, PLC, Plant City, Florida, United States

Alternative Solutions, LLC, Saint Petersburg, Florida, United States

Precision Clinical Research, LLC, Sunrise, Florida, United States

Clinical Trials of Tampa, Tampa, Florida, United States

Summit Clinical Research, LLC, Athens, Georgia, United States

Augusta University, Augusta, Georgia, United States

Atlanta Center for Gastroenterology, P.C., Decatur, Georgia, United States

Infinite Clinical Trials, Morrow, Georgia, United States

Grand Teton Research Group, Idaho Falls, Idaho, United States

Christie Clinic, LLC, Champaign, Illinois, United States

Rush University Medical Center, Chicago, Illinois, United States

GI Partners of IL / Avicenna, Downers Grove, Illinois, United States

Edward Hines Jr. VA Hospital, Hines, Illinois, United States

Southwest Gastroenterology, Oak Lawn, Illinois, United States

Margaret Mary Health, Batesville, Indiana, United States

Deaconess Clinic, Inc., Evansville, Indiana, United States

Richard L. Roudebush VA Medical Center, Indianapolis, Indiana, United States

Deaconess Clinic, Inc., Newburgh, Indiana, United States

The South Bend Clinic, South Bend, Indiana, United States

PMG Research, Ames, Iowa, United States

University of Iowa, Iowa City, Iowa, United States

The Iowa Clinic, P.C., West Des Moines, Iowa, United States

Digestive Health Center of the Four States, LLC, Galena, Kansas, United States

Hutchinson Clinic, Hutchinson, Kansas, United States

Ascension Via Christi Hospitals Wichita, Inc, Wichita, Kansas, United States

St. Elizabeth Healthcare, Edgewood, Kentucky, United States

Horizon Research Group of Opelousas, LLC, Eunice, Louisiana, United States

Houma Digestive Health Specialists-CroNOLA, Houma, Louisiana, United States

Combined Gastro Research, LLC, Lafayette, Louisiana, United States

Clinical Trials of SWLA, LLC, Lake Charles, Louisiana, United States

Clinical Trials Management, LLC, Metairie, Louisiana, United States

New Orleans Research Institute, Metairie, Louisiana, United States

Delta Research Partners, Monroe, Louisiana, United States

Louisiana Research Center; Gastrointestinal Associates, Shreveport, Louisiana, United States

Clinical Trials of America, LLC, West Monroe, Louisiana, United States

Gastro Health Research, Annapolis, Maryland, United States

Chevy Chase Clinical Research, Chevy Chase, Maryland, United States

Centennial Medical Group, Elkridge, Maryland, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center - Harvard, Boston, Massachusetts, United States

IQVIA RDS, Inc., Cambridge, Massachusetts, United States

Digestive Health Specialists, PC, Chelmsford, Massachusetts, United States

NECCR PrimaCare Research, LLC, Fall River, Massachusetts, United States

University of Massachusetts - Worcester, Worcester, Massachusetts, United States

University of Michigan, Ann Arbor, Michigan, United States

Oakland Medical Research, Troy, Michigan, United States

Clinical Research Institute of Michigan, LLC, Troy, Michigan, United States

Mayo Clinic, Rochester, Minnesota, United States

Southern Therapy and Advanced Research LLC (STAR), Jackson, Mississippi, United States

Clinical Research Professionals, Chesterfield, Missouri, United States

Sundance Clinical Research, LLC, Saint Louis, Missouri, United States

Methodist Physicians Clinic / CCT Research, Fremont, Nebraska, United States

CHI Nebraska, Omaha, Nebraska, United States

University of Nevada, Las Vegas, Las Vegas, Nevada, United States

Clinical Research of South Nevada, Las Vegas, Nevada, United States

Digestive Health Associates, Reno, Nevada, United States

AGA Clinical Research Associates, LLC, Egg Harbor Township, New Jersey, United States

Allied Health Clinical Research Organization, LLC, West Long Branch, New Jersey, United States

United Health Services Hospitals, Inc., Binghamton, New York, United States

VA NY Harbor HCS- Brooklyn Campus, Brooklyn, New York, United States

Sing Chan, MD, Flushing, New York, United States

Mid Hudson Medical Research, PLLC, New Windsor, New York, United States

Icahn School of Medicine at Mount Sinai, New York, New York, United States

DiGiovanna Institute for Medical Education & Research, North Massapequa, New York, United States

Digestive Health Partners, PA, Asheville, North Carolina, United States

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Atrium Health Department of Family Medicine Research, Charlotte, North Carolina, United States

Javara, Charlotte, North Carolina, United States

Coastal Research Institute, LLC, Fayetteville, North Carolina, United States

Medication Management LLC, Greensboro, North Carolina, United States

Peters Medical Research, High Point, North Carolina, United States

Clinical Trials of America, LLC, Mount Airy, North Carolina, United States

Coastal Carolina Health Care, P.A., New Bern, North Carolina, United States

Trial Management Associates, LLC, Wilmington, North Carolina, United States

Lillestol Research, LLC, Fargo, North Dakota, United States

Plains Clinical Research Center, LLC, Fargo, North Dakota, United States

Great Lakes Medical Research, LLC, Beachwood, Ohio, United States

Gastro Health Research, Cincinnati, Ohio, United States

Hightop Medical Research Clinic, Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

Dayton Clinical Resesarch, Dayton, Ohio, United States

META Medical Research Institute, LLC, Dayton, Ohio, United States

Great Lakes Gastroenterology Research, LLC, Mentor, Ohio, United States

Paramount Medical Research and Consulting, LLC, Middleburg Heights, Ohio, United States

Northshore Gastroenterology Research, LLC, Westlake, Ohio, United States

Comprehensive Internal Medicine, Inc, Wooster, Ohio, United States

Alliance for Multispecialty Research, LLC, Norman, Oklahoma, United States

SSM Health Medical Group/Hightower Clinical, Oklahoma City, Oklahoma, United States

Options Health Research, LLC, Tulsa, Oklahoma, United States

Great Lakes Medical Research, LLC, Harrisburg, Pennsylvania, United States

Richard M. Kastelic, M.D., and Associates, P.C., Johnstown, Pennsylvania, United States

Regional GI, Lancaster, Pennsylvania, United States

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Care Access Research, Pottsville, Pottsville, Pennsylvania, United States

Ralph H. Johnson VAMC, Charleston, South Carolina, United States

Pharmacorp Clinical Trials, Inc., Charleston, South Carolina, United States

Invocare Medical Research & Healthcare Center, West Columbia, South Carolina, United States

Rapid City Medical Center, LLP, Rapid City, South Dakota, United States

WR-ClinSearch, LLC, Chattanooga, Tennessee, United States

Gastro One, Germantown, Tennessee, United States

The Jackson Clinic, PA, Jackson, Tennessee, United States

Clinical Research Solutions, LLC - TN, Jackson, Tennessee, United States

The Jackson Clinic, PA, Jackson, Tennessee, United States

Tri-Cities, Kingsport, Tennessee, United States

Great Lakes Medical Research, LLC, Union City, Tennessee, United States

ARC Clinical Research at Four Points, Austin, Texas, United States

Elligo Health Research Inc., Austin, Texas, United States

ARC Clinical Research at William Cannon, Austin, Texas, United States

Avant Research Associates, Austin, Texas, United States

Mercy Family Clinic, Dallas, Texas, United States

Dharma PA D/B/A Southwest Family Medicine Associates, Dallas, Texas, United States

Texas Tech University Health Sciences Center El Paso, El Paso, Texas, United States

Houston Digestive Disease, Houston, Texas, United States

UT MD Anderson Cancer Center, Houston, Texas, United States

Biopharma Informatic, LLC, Houston, Texas, United States

Fairway Medical Clinic, Houston, Texas, United States

Digestive System Healthcare, Houston, Texas, United States

FMC Science, LLC, Lampasas, Texas, United States

Rio Grande Gastroenterology, McAllen, Texas, United States

Wellness Clinical Research, McKinney, Texas, United States

ARC Clinical Research at Kelly Lane, Pflugerville, Texas, United States

Epic Medical Research, LLC, Red Oak, Texas, United States

Clinical Associates in Research Therapeutics of America, San Antonio, Texas, United States

Gastroenterology Research of San Antonio, San Antonio, Texas, United States

Texas Gastro Consultants, Tomball, Texas, United States

Progressive Clinical Research, LLC, Bountiful, Utah, United States

Tanner Clinic, Layton, Utah, United States

Advanced Research Institute, Ogden, Utah, United States

Advanced Clinical Research, Riverton, Utah, United States

Granger Medical Clinic, Riverton, Utah, United States

Advanced Research Institute, Sandy, Utah, United States

Blue Ridge Medical Research, Lynchburg, Virginia, United States

Summit Clinical Research, Petersburg, Virginia, United States

Central Virginia VA Healthcare System, Richmond, Virginia, United States

Virginia Gastroenterology Institute, Suffolk, Virginia, United States

Benaroya Research Institute at Virginia Mason, Seattle, Washington, United States

Spokane Gastroenterology, Spokane, Washington, United States

Wenatchee Valley Hospital, Wenatchee, Washington, United States

University Physicians and Surgeons, Inc. DBA Marshall Health, Huntington, West Virginia, United States

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

Ascension Wisconsin, Milwaukee, Wisconsin, United States

Wisconsin Center for Advanced Research, Milwaukee, Wisconsin, United States

Contact Details

Name: Thomas Imperiale, MD

Affiliation: Indiana University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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