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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04144751
Other study ID # 2019-01B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2019
Est. completion date March 30, 2023

Study information

Verified date August 2023
Source Exact Sciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 23494
Est. completion date March 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Criteria: 1. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Locations

Country Name City State
United States Cornerstone Research Institute Altamonte Springs Florida
United States PMG Research Ames Iowa
United States University of Michigan Ann Arbor Michigan
United States Gastro Health Research Annapolis Maryland
United States Digestive Health Partners, PA Asheville North Carolina
United States Summit Clinical Research, LLC Athens Georgia
United States Augusta University Augusta Georgia
United States ARC Clinical Research at Four Points Austin Texas
United States ARC Clinical Research at William Cannon Austin Texas
United States Avant Research Associates Austin Texas
United States Elligo Health Research Inc Austin Texas
United States Great Lakes Medical Research LLC Beachwood Ohio
United States United Health Services Hospitals, Inc. Binghamton New York
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 Beth Israel Deaconess Medical Center - Harvard Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Progressive Clinical Research, LLC Bountiful Utah
United States Bridgeport Hospital Bridgeport Connecticut
United States Gastroenterology Associates of Fairfield County Bridgeport Connecticut
United States Connecticut Clinical Research Institute Bristol Connecticut
United States VA NY Harbor HCS- Brooklyn Campus Brooklyn New York
United States Fomat Medical Research Camarillo California
United States IQVIA RDS, Inc. Cambridge Massachusetts
United States Alliance Research Institute Canoga Park California
United States Christie Clinic Champaign Illinois
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Pharmacorp Clinical Trials, Inc. Charleston South Carolina
United States Ralph H. Johnson VAMC Charleston South Carolina
United States Atrium Health Department of Family Medicine Research Charlotte North Carolina
United States Javara Charlotte North Carolina
United States WR-ClinSearch, LLC Chattanooga Tennessee
United States Digestive Health Specialists, PC Chelmsford Massachusetts
United States Clinical Research Professionals Chesterfield Missouri
United States Chevy Chase Clinical Research Chevy Chase Maryland
United States Rush University Medical Center Chicago Illinois
United States GW Research Inc Chula Vista California
United States Gastro Health Research Cincinnati Ohio
United States Hightop Medical Research Center Cincinnati Ohio
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Cullman Clinical Trials Cullman Alabama
United States Dharma PA D/B/A Southwest Family Medicine Associates Dallas Texas
United States Mercy Family Clinic Dallas Texas
United States Dayton Clinical Research Dayton Ohio
United States META Medical Research Institute, LLC Dayton Ohio
United States Atlanta Center for Gastroenterology, P.C. Decatur Georgia
United States Digestive Health Specialists of the Southeast Dothan Alabama
United States GI Partners of IL / Avicenna Downers Grove Illinois
United States St. Elizabeth Healthcare Edgewood Kentucky
United States AGA Clinical Research Associates, LLC Egg Harbor Township New Jersey
United States Texas Tech University Health Sciences Center El Paso El Paso Texas
United States Centennial Medical Group Elkridge Maryland
United States Horizon Research Group of Opelousas, LLC Eunice Louisiana
United States Deaconess Clinic, Inc. Evansville Indiana
United States NECCR PrimaCare Research, LLC Fall River Massachusetts
United States Lillestol Research, LLC Fargo North Dakota
United States Plains Clinical Research Center, LLC Fargo North Dakota
United States Coastal Research Institute, LLC Fayetteville North Carolina
United States Sing Chan, MD Flushing New York
United States G & L Research Foley Alabama
United States Vanguard Clinical Research Fort Myers Florida
United States Methodist Physicians Clinic / CCT Research Fremont Nebraska
United States SIMED Health Research Gainesville Florida
United States Digestive Health Center of the Four States, LLC Galena Kansas
United States Paragon Rx Clinical, Inc. Garden Grove California
United States Gastro One Germantown Tennessee
United States New West Physicians Golden Colorado
United States Medication Management LLC Greensboro North Carolina
United States Great Lakes Medical Research, LLC Harrisburg Pennsylvania
United States Peters Medical Research High Point North Carolina
United States Edward Hines Jr. VA Hospital Hines Illinois
United States Houma Digestive Health Specialists-CroNOLA Houma Louisiana
United States Biopharma Informatic, LLC Houston Texas
United States Digestive System Healthcare Houston Texas
United States Fairway Medical Clinic Houston Texas
United States Houston Digestive Disease Houston Texas
United States UT MD Anderson Cancer Center Houston Texas
United States University Physicians and Surgeons, Inc.(Marshall Health) Huntington West Virginia
United States Medical Affiliated Research Center Huntsville Alabama
United States Hutchinson Clinic Hutchinson Kansas
United States Grand Teton Research Group Idaho Falls Idaho
United States University of Iowa Iowa City Iowa
United States United Medical Doctors Irvine California
United States Clinical Research Solutions, LLC - TN Jackson Tennessee
United States Southern Therapy and Advanced Research LLC (STAR) Jackson Mississippi
United States The Jackson Clinic, PA Jackson Tennessee
United States The Jackson Clinic, PA Jackson Tennessee
United States Shands Jacksonville Medical Center, Inc - University of Florida Health Jacksonville Florida
United States Westside Center of Clinical Research Jacksonville Florida
United States Richard M. Kastelic, M.D., and Associates, P.C. Johnstown Pennsylvania
United States Health Awareness, Inc. Jupiter Florida
United States Tri-Cities Gastroenterology Kingsport Tennessee
United States Combined Gastro Research. LLC Lafayette Louisiana
United States Prime Care Clinical Research Center Laguna Hills California
United States Clinical Trials of SWLA, LLC Lake Charles Louisiana
United States Wr-Msra, Llc Lake City Florida
United States FMC Science, LLC Lampasas Texas
United States Gastro Care Institute Lancaster California
United States Regional GI Lancaster Pennsylvania
United States Clinical Research of South Nevada Las Vegas Nevada
United States University of Nevada, Las Vegas Las Vegas Nevada
United States Tanner Clinic Layton Utah
United States Alliance Medical Research Lighthouse Point Florida
United States Applied Research Center of Arkansas Little Rock Arkansas
United States Lynn Institute of the Ozarks Little Rock Arkansas
United States Blue Ridge Medical Research Lynchburg Virginia
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Rio Grande Gastroenterology McAllen Texas
United States Wellness Clinical Research McKinney Texas
United States Great Lakes Gastroenterology Research, LLC Mentor Ohio
United States Clinical Trials Management, LLC Metairie Louisiana
United States New Orleans Research Institute Metairie Louisiana
United States Gastro Health Research Miami Florida
United States Next Phase Research Alliance Miami Florida
United States Research Associates of South Florida, LLC Miami Florida
United States Suncoast Research Group, LLC Miami Florida
United States Paramount Medical Research and Consulting, LLC Middleburg Heights Ohio
United States Wisconsin Center for Advanced Research Milwaukee Wisconsin
United States Facey Medical Foundation Mission Hills California
United States East View Medical Research, LLC Mobile Alabama
United States Delta Research Partners Monroe Louisiana
United States Infinite Clinical Trials Morrow Georgia
United States Clinical Trials of America, LLC Mount Airy North Carolina
United States Gastroenterology Group of Naples Naples Florida
United States Coastal Carolina Health Care, P.A New Bern North Carolina
United States Yale University New Haven Connecticut
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 Deaconess Clinic, Inc. Newburgh Indiana
United States Alliance for Multispecialty Research, LLC Norman Oklahoma
United States Arkansas Gastroenterology, P.A. North Little Rock Arkansas
United States DiGiovanna Institute for Medical Education & Research North Massapequa New York
United States Southwest Gastroenterology Oak Lawn Illinois
United States Sarkis Clinical Trials Ocala Florida
United States Advanced Research Institute Ogden Utah
United States SSM Health Medical Group/Hightower Clinical Oklahoma City Oklahoma
United States CHI Nebraska Omaha Nebraska
United States Knowledge Research Center Orange California
United States Desert Oasis Healthcare Medical Group Palm Springs California
United States Imic, Inc. Palmetto Bay Florida
United States Palo Alto Veterans Institute for Research Palo Alto California
United States Summit Clinical Research Petersburg Virginia
United States ARC Clinical Research at Kelly Lane Pflugerville Texas
United States Thomas Jefferson University Philadelphia Philadelphia Pennsylvania
United States Mayo Clinic - AZ Phoenix Arizona
United States Family Medical Specialists of Florida, PLC Plant City Florida
United States Care Access Research, Pottsville Pottsville Pennsylvania
United States Rapid City Medical Center, LLP Rapid City South Dakota
United States Epic Medical Research LLC Red Oak Texas
United States Digestive Health Associates Reno Nevada
United States Central Virginia VA Healthcare System Richmond Virginia
United States Advanced Clinical Research Riverton Utah
United States Granger Medical Clinic Riverton Utah
United States Mayo Clinic Rochester Minnesota
United States Sundance Clinical Research, LLC Saint Louis Missouri
United States Alternative Solutions, LLC Saint Petersburg Florida
United States Clinical Associates in Research Therapeutics of America San Antonio Texas
United States Gastroenterology Research of San Antonio San Antonio Texas
United States SDG Clinical Research San Diego California
United States San Jose Gastroenterology San Jose California
United States Advanced Research Institute Sandy Utah
United States Paragon Rx Clinical, Inc. - Santa Ana Santa Ana California
United States Sansum Clinic Santa Barbara California
United States Benaroya Research Institute at Virginia Mason Seattle Washington
United States Unison Clinical Trials Sherman Oaks California
United States Louisiana Research Center; Gastrointestinal Associates Shreveport Louisiana
United States The South Bend Clinic South Bend Indiana
United States Spokane Gastroenterology Spokane Washington
United States Virginia Gastroenterology Institute Suffolk Virginia
United States A & U Family Medicine Sugar Land Texas
United States Precision Clinical Research, LLC Sunrise Florida
United States Clinical Trials of Tampa Tampa Florida
United States Millennium Clinical Trials Thousand Oaks California
United States Texas Gastro Consultants Tomball Texas
United States Center for Digestive Health Research Troy Michigan
United States Oakland Medical Research Troy Michigan
United States Oakland Medical Research Center Troy Michigan
United States Del Sol Research Management, LLC Tucson Arizona
United States Southern Arizona VA Health Care System (SAVAHCS) Tucson Arizona
United States Options Health Research, LLC Tulsa Oklahoma
United States GI Associates of West Alabama, P.C Tuscaloosa Alabama
United States Great Lakes Medical Research, LLC Union City Tennessee
United States Dream Team Clinical Research Upland California
United States Wentachee Valley Hospital Wenatchee Washington
United States Invocare Medical Research & Healthcare Center West Columbia South Carolina
United States The Iowa Clinic, P.C. West Des Moines Iowa
United States Allied Health Clinical Research Organization, LLC West Long Branch New Jersey
United States Clinical Trials of America, LLC West Monroe Louisiana
United States Northshore Gastroenterology Research, LLC Westlake Ohio
United States Ascension Via Christi Hospitals Wichita, Inc Wichita Kansas
United States Trial Management Associates, LLC Wilmington North Carolina
United States Comprehensive Internal Medicine, Inc Wooster Ohio
United States University of Massachusetts - Worcester Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood-based biomarkers associated with genetic and epigenetic alterations. Point in time blood collection (1 day) at enrollment
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