Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "Clinical Validation of an Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C"

Last updated: September 26, 2023
Sponsor: Exact Sciences Corporation
Overall Status: Completed

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer

Colon Cancer; Rectal Cancer

Treatment

Blood Sample Collection

Clinical Study ID

NCT04144751
2019-01B
  • Ages > 40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary objective of this sub-study, 2019-01B, is to collect blood specimens for research use in the development and validation of a blood-based test for colorectal cancer (CRC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is currently enrolled in Exact Sciences Protocol 2019-01 BLUE-C.
  2. Subject is willing and able to provide a blood sample.
  3. Subject is willing and able to sign informed consent.

Exclusion

Exclusion Criteria:

  1. Subject has any condition that in the opinion of the Investigator should precludeparticipation in the study.

Study Design

Total Participants: 23494
Treatment Group(s): 1
Primary Treatment: Blood Sample Collection
Phase:
Study Start date:
November 15, 2019
Estimated Completion Date:
March 30, 2023

Study Description

Subjects who consent to enroll in Exact Sciences Protocol 2019-01 BLUE-C, will be invited to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2019-01 BLUE-C, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.

Connect with a study center

  • A.O.U. Policlinico G.Martino

    Messina, 98125
    Italy

    Site Not Available

  • Wright Clinical Research, LLC

    Alabaster, Alabama 35007
    United States

    Site Not Available

  • Parkway Medical Center

    Birmingham, Alabama 35215
    United States

    Site Not Available

  • Summit Internal Medicine, PC

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Wright Clinical Research, LLC

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • Cullman Clinical Trials

    Cullman, Alabama 35055
    United States

    Site Not Available

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama 36301
    United States

    Site Not Available

  • G & L Research

    Foley, Alabama 36535
    United States

    Site Not Available

  • Medical Affiliated Research Center

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • East View Medical Research, LLC

    Mobile, Alabama 36608
    United States

    Site Not Available

  • GI Associates of West Alabama, P.C

    Tuscaloosa, Alabama 35406
    United States

    Site Not Available

  • Mayo Clinic - AZ

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Del Sol Research Management, LLC

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Southern Arizona VA Health Care System (SAVAHCS)

    Tucson, Arizona 85723
    United States

    Site Not Available

  • Applied Research Center of Arkansas

    Little Rock, Arkansas 72212
    United States

    Site Not Available

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas 72204
    United States

    Site Not Available

  • Arkansas Gastroenterology, P.A.

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • Fomat Medical Research

    Camarillo, California 93012
    United States

    Site Not Available

  • Alliance Research Institute

    Canoga Park, California 91304
    United States

    Site Not Available

  • GW Research Inc

    Chula Vista, California 91910
    United States

    Site Not Available

  • Paragon Rx Clinical, Inc.

    Garden Grove, California 92840
    United States

    Site Not Available

  • United Medical Doctors

    Irvine, California 92618
    United States

    Site Not Available

  • Prime Care Clinical Research Center

    Laguna Hills, California 92656
    United States

    Site Not Available

  • Gastro Care Institute

    Lancaster, California 93534
    United States

    Site Not Available

  • Facey Medical Foundation

    Mission Hills, California 91345
    United States

    Site Not Available

  • Knowledge Research Center

    Orange, California 92868
    United States

    Site Not Available

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California 92262
    United States

    Site Not Available

  • Palo Alto Veterans Institute for Research

    Palo Alto, California 34304
    United States

    Site Not Available

  • SDG Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • San Jose Gastroenterology

    San Jose, California 95116
    United States

    Site Not Available

  • Paragon Rx Clinical, Inc. - Santa Ana

    Santa Ana, California 92703
    United States

    Site Not Available

  • Sansum Clinic

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Unison Clinical Trials

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Millennium Clinical Trials

    Thousand Oaks, California 91360
    United States

    Site Not Available

  • Dream Team Clinical Research

    Upland, California 91786
    United States

    Site Not Available

  • New West Physicians

    Golden, Colorado 80401
    United States

    Site Not Available

  • Bridgeport Hospital

    Bridgeport, Connecticut 06610
    United States

    Site Not Available

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • Connecticut Clinical Research Institute

    Bristol, Connecticut 06010
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Cornerstone Research Institute

    Altamonte Springs, Florida 32701
    United States

    Site Not Available

  • Vanguard Clinical Research

    Fort Myers, Florida 33907
    United States

    Site Not Available

  • SIMED Health Research

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Shands Jacksonville Medical Center, Inc - University of Florida Health

    Jacksonville, Florida 32206
    United States

    Site Not Available

  • Westside Center of Clinical Research

    Jacksonville, Florida 32205
    United States

    Site Not Available

  • Health Awareness, Inc.

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Multi-Specialty Research Associates

    Lake City, Florida 32055
    United States

    Site Not Available

  • Wr-Msra, Llc

    Lake City, Florida 32055
    United States

    Site Not Available

  • Alliance Medical Research

    Lighthouse Point, Florida 33064
    United States

    Site Not Available

  • Gastro Health Research

    Miami, Florida 33176
    United States

    Site Not Available

  • Next Phase Research Alliance

    Miami, Florida 33144
    United States

    Site Not Available

  • Research Associates of South Florida, LLC

    Miami, Florida 33156
    United States

    Site Not Available

  • Suncoast Research Group, LLC

    Miami, Florida 33135
    United States

    Site Not Available

  • Gastroenterology Group of Naples

    Naples, Florida 34102
    United States

    Site Not Available

  • Sarkis Clinical Trials

    Ocala, Florida 34471
    United States

    Site Not Available

  • Imic, Inc.

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • Family Medical Specialists of Florida, PLC

    Plant City, Florida 33563
    United States

    Site Not Available

  • Alternative Solutions, LLC

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Precision Clinical Research, LLC

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Clinical Trials of Tampa

    Tampa, Florida 33614
    United States

    Site Not Available

  • Summit Clinical Research, LLC

    Athens, Georgia 30607
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Infinite Clinical Trials

    Morrow, Georgia 30260
    United States

    Site Not Available

  • Infinite Clinical Trials

    Riverdale, Georgia 30274
    United States

    Site Not Available

  • Grand Teton Research Group

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Christie Clinic

    Champaign, Illinois 61882
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • GI Partners of IL / Avicenna

    Downers Grove, Illinois 60515
    United States

    Site Not Available

  • Edward Hines Jr. VA Hospital

    Hines, Illinois 60141
    United States

    Site Not Available

  • Southwest Gastroenterology

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Deaconess Clinic, Inc.

    Evansville, Indiana 47713
    United States

    Site Not Available

  • Deaconess Clinic, Inc.

    Newburgh, Indiana 47630
    United States

    Site Not Available

  • The South Bend Clinic

    South Bend, Indiana 46617
    United States

    Site Not Available

  • PMG Research

    Ames, Iowa 50010
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • The Iowa Clinic, P.C.

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Digestive Health Center of the Four States, LLC

    Galena, Kansas 66739
    United States

    Site Not Available

  • Hutchinson Clinic

    Hutchinson, Kansas 67502
    United States

    Site Not Available

  • Ascension Via Christi Hospitals Wichita, Inc

    Wichita, Kansas 67214
    United States

    Site Not Available

  • St. Elizabeth Healthcare

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • Horizon Research Group of Opelousas, LLC

    Eunice, Louisiana 70535
    United States

    Site Not Available

  • Houma Digestive Health Specialists-CroNOLA

    Houma, Louisiana 70360
    United States

    Site Not Available

  • Combined Gastro Research. LLC

    Lafayette, Louisiana 70503
    United States

    Site Not Available

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana 70601
    United States

    Site Not Available

  • Clinical Trials Management, LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • New Orleans Research Institute

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Delta Research Partners

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Louisiana Research Center; Gastrointestinal Associates

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Clinical Trials of America, LLC

    West Monroe, Louisiana 71291
    United States

    Site Not Available

  • Gastro Health Research

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Centennial Medical Group

    Elkridge, Maryland 21075
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center - Harvard

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • IQVIA RDS, Inc.

    Cambridge, Massachusetts 02139
    United States

    Site Not Available

  • Digestive Health Specialists, PC

    Chelmsford, Massachusetts 01824
    United States

    Site Not Available

  • NECCR PrimaCare Research, LLC

    Fall River, Massachusetts 02721
    United States

    Site Not Available

  • University of Massachusetts - Worcester

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Center for Digestive Health Research

    Troy, Michigan 48098
    United States

    Site Not Available

  • Oakland Medical Research

    Troy, Michigan 48085
    United States

    Site Not Available

  • Oakland Medical Research Center

    Troy, Michigan 48085
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Southern Therapy and Advanced Research LLC (STAR)

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Sundance Clinical Research, LLC

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Methodist Physicians Clinic / CCT Research

    Fremont, Nebraska 68025
    United States

    Site Not Available

  • CHI Nebraska

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Clinical Research of South Nevada

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • University of Nevada, Las Vegas

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Digestive Health Associates

    Reno, Nevada 89511
    United States

    Site Not Available

  • AGA Clinical Research Associates, LLC

    Egg Harbor Township, New Jersey 08234
    United States

    Site Not Available

  • Allied Health Clinical Research Organization, LLC

    West Long Branch, New Jersey 07728
    United States

    Site Not Available

  • United Health Services Hospitals, Inc.

    Binghamton, New York 13903
    United States

    Site Not Available

  • VA NY Harbor HCS- Brooklyn Campus

    Brooklyn, New York 11209
    United States

    Site Not Available

  • Sing Chan, MD

    Flushing, New York 11354
    United States

    Site Not Available

  • Mid Hudson Medical Research, PLLC

    New Windsor, New York 12553
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • DiGiovanna Institute for Medical Education & Research

    North Massapequa, New York 11758
    United States

    Site Not Available

  • Digestive Health Partners, PA

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Atrium Health Department of Family Medicine Research

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Javara

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Coastal Research Institute, LLC

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Medication Management LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Peters Medical Research

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Clinical Trials of America, LLC

    Mount Airy, North Carolina 27030
    United States

    Site Not Available

  • Coastal Carolina Health Care, P.A

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Wr-Msra, Llc

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Trial Management Associates, LLC

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Lillestol Research, LLC

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Plains Clinical Research Center, LLC

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Great Lakes Medical Research LLC

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Consultants for Clinical Research

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Gastro Health Research

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Hightop Medical Research Center

    Cincinnati, Ohio 45224
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Dayton Clinical Research

    Dayton, Ohio 45409
    United States

    Site Not Available

  • META Medical Research Institute, LLC

    Dayton, Ohio 45432
    United States

    Site Not Available

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Paramount Medical Research and Consulting, LLC

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio 44145
    United States

    Site Not Available

  • Comprehensive Internal Medicine, Inc

    Wooster, Ohio 44691
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • SSM Health Medical Group/Hightower Clinical

    Oklahoma City, Oklahoma 73102
    United States

    Site Not Available

  • Options Health Research, LLC

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Great Lakes Medical Research, LLC

    Harrisburg, Pennsylvania 17110
    United States

    Site Not Available

  • Richard M. Kastelic, M.D., and Associates, P.C.

    Johnstown, Pennsylvania 15905
    United States

    Site Not Available

  • Regional GI

    Lancaster, Pennsylvania 17601
    United States

    Site Not Available

  • Thomas Jefferson University Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Care Access Research, Pottsville

    Pottsville, Pennsylvania 17901
    United States

    Site Not Available

  • Pharmacorp Clinical Trials, Inc.

    Charleston, South Carolina 29412
    United States

    Site Not Available

  • Ralph H. Johnson VAMC

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Invocare Medical Research & Healthcare Center

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Rapid City Medical Center, LLP

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Clinical Research Solutions, LLC - TN

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • The Jackson Clinic, PA

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Tri-Cities Gastroenterology

    Kingsport, Tennessee 37663
    United States

    Site Not Available

  • Great Lakes Medical Research, LLC

    Union City, Tennessee 38261
    United States

    Site Not Available

  • ARC Clinical Research at Four Points

    Austin, Texas 78726
    United States

    Site Not Available

  • ARC Clinical Research at William Cannon

    Austin, Texas 78745
    United States

    Site Not Available

  • Avant Research Associates

    Austin, Texas 78748
    United States

    Site Not Available

  • Elligo Health Research Inc

    Austin, Texas 78738
    United States

    Site Not Available

  • Dharma PA D/B/A Southwest Family Medicine Associates

    Dallas, Texas 75235
    United States

    Site Not Available

  • Mercy Family Clinic

    Dallas, Texas 75211
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center El Paso

    El Paso, Texas 79905
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77084
    United States

    Site Not Available

  • Digestive System Healthcare

    Houston, Texas 77505
    United States

    Site Not Available

  • Fairway Medical Clinic

    Houston, Texas 77087
    United States

    Site Not Available

  • Houston Digestive Disease

    Houston, Texas 77030
    United States

    Site Not Available

  • UT MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • FMC Science, LLC

    Lampasas, Texas 76550
    United States

    Site Not Available

  • Rio Grande Gastroenterology

    McAllen, Texas 78503
    United States

    Site Not Available

  • Wellness Clinical Research

    McKinney, Texas 75071
    United States

    Site Not Available

  • ARC Clinical Research at Kelly Lane

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Epic Medical Research LLC

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Clinical Associates in Research Therapeutics of America

    San Antonio, Texas 78212
    United States

    Site Not Available

  • Gastroenterology Research of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • A & U Family Medicine

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Texas Gastro Consultants

    Tomball, Texas 77375
    United States

    Site Not Available

  • Progressive Clinical Research, LLC

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Tanner Clinic

    Layton, Utah 84041
    United States

    Site Not Available

  • Advanced Research Institute

    Ogden, Utah 84405
    United States

    Site Not Available

  • Advanced Clinical Research

    Riverton, Utah 84065
    United States

    Site Not Available

  • Granger Medical Clinic

    Riverton, Utah 84096
    United States

    Site Not Available

  • Advanced Research Institute

    Sandy, Utah 84092
    United States

    Site Not Available

  • Blue Ridge Medical Research

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Summit Clinical Research

    Petersburg, Virginia 23805
    United States

    Site Not Available

  • Central Virginia VA Healthcare System

    Richmond, Virginia 23249
    United States

    Site Not Available

  • Virginia Gastroenterology Institute

    Suffolk, Virginia 23434
    United States

    Site Not Available

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington 98101
    United States

    Site Not Available

  • Spokane Gastroenterology

    Spokane, Washington 99202
    United States

    Site Not Available

  • Wentachee Valley Hospital

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • University Physicians and Surgeons, Inc.(Marshall Health)

    Huntington, West Virginia 25701
    United States

    Site Not Available

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53215
    United States

    Site Not Available

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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