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"
- Conditions
- Colorectal Cancer
- Interventions
- Other: Blood Sample Collection
- Registration Number
- NCT04144751
- Lead Sponsor
- Exact Sciences Corporation
- Brief 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).
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23494
- Subject is currently enrolled in Exact Sciences Protocol 2019-01 BLUE-C.
- Subject is willing and able to provide a blood sample.
- Subject is willing and able to sign informed consent.
- 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 Subjects Enrolled in 2019-01 BLUE-C Blood Sample Collection Subjects will be men and women, 40 years of age or older, who enroll in Exact Sciences Protocol 2019-01 BLUE-C. Subjects will provide a blood sample at time of enrollment.
- Primary Outcome Measures
Name Time Method Blood-based biomarkers associated with genetic and epigenetic alterations. Point in time blood collection (1 day) at enrollment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (187)
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center - Harvard
🇺🇸Boston, Massachusetts, United States
NECCR PrimaCare Research, LLC
🇺🇸Fall River, Massachusetts, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Texas Gastro Consultants
🇺🇸Tomball, Texas, United States
Thomas Jefferson University Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Tri-Cities Gastroenterology
🇺🇸Kingsport, Tennessee, United States
Mercy Family Clinic
🇺🇸Dallas, Texas, United States
Houston Digestive Disease
🇺🇸Houston, Texas, United States
Methodist Physicians Clinic / CCT Research
🇺🇸Fremont, Nebraska, United States
VA NY Harbor HCS- Brooklyn Campus
🇺🇸Brooklyn, New York, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
PMG Research
🇺🇸Ames, Iowa, United States
Oakland Medical Research
🇺🇸Troy, Michigan, United States
Center for Digestive Health Research
🇺🇸Troy, Michigan, United States
St. Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, 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
SDG Clinical Research
🇺🇸San Diego, California, United States
Gastro Health Research
🇺🇸Cincinnati, Ohio, United States
University of Nevada, Las Vegas
🇺🇸Las Vegas, Nevada, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
Clinical Associates in Research Therapeutics of America
🇺🇸San Antonio, Texas, United States
Mayo Clinic - AZ
🇺🇸Phoenix, Arizona, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
CHI Nebraska
🇺🇸Omaha, Nebraska, United States
Southern Arizona VA Health Care System (SAVAHCS)
🇺🇸Tucson, Arizona, United States
Great Lakes Medical Research LLC
🇺🇸Beachwood, Ohio, United States
United Health Services Hospitals, Inc.
🇺🇸Binghamton, New York, United States
Summit Internal Medicine, PC
🇺🇸Birmingham, Alabama, United States
Louisiana Research Center; Gastrointestinal Associates
🇺🇸Shreveport, Louisiana, United States
Options Health Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Clinical Trials of Tampa
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, 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
Gastroenterology Associates of Fairfield County
🇺🇸Bridgeport, Connecticut, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Palo Alto Veterans Institute for Research
🇺🇸Palo Alto, California, United States
San Jose Gastroenterology
🇺🇸San Jose, California, United States
GW Research Inc
🇺🇸Chula Vista, California, United States
Paragon Rx Clinical, Inc.
🇺🇸Garden Grove, California, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Millennium Clinical Trials
🇺🇸Thousand Oaks, California, United States
Connecticut Clinical Research Institute
🇺🇸Bristol, Connecticut, United States
Cornerstone Research Institute
🇺🇸Altamonte Springs, Florida, United States
Imic, Inc.
🇺🇸Palmetto Bay, Florida, United States
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
Gastro Care Institute
🇺🇸Lancaster, California, United States
Atlanta Center for Gastroenterology, P.C.
🇺🇸Decatur, Georgia, United States
Augusta University
🇺🇸Augusta, Georgia, United States
The South Bend Clinic
🇺🇸South Bend, Indiana, United States
SIMED Health Research
🇺🇸Gainesville, Florida, United States
Rapid City Medical Center, LLP
🇺🇸Rapid City, South Dakota, United States
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
Desert Oasis Healthcare Medical Group
🇺🇸Palm Springs, California, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Facey Medical Foundation
🇺🇸Mission Hills, California, United States
Unison Clinical Trials
🇺🇸Sherman Oaks, California, United States
Precision Clinical Research, LLC
🇺🇸Sunrise, Florida, United States
Hutchinson Clinic
🇺🇸Hutchinson, Kansas, United States
Richard M. Kastelic, M.D., and Associates, P.C.
🇺🇸Johnstown, Pennsylvania, United States
Digestive Health Center of the Four States, LLC
🇺🇸Galena, Kansas, United States
Prime Care Clinical Research Center
🇺🇸Laguna Hills, California, United States
AGA Clinical Research Associates, LLC
🇺🇸Egg Harbor Township, New Jersey, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Southern Therapy and Advanced Research LLC (STAR)
🇺🇸Jackson, Mississippi, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Shands Jacksonville Medical Center, Inc - University of Florida Health
🇺🇸Jacksonville, Florida, United States
Vanguard Clinical Research
🇺🇸Fort Myers, Florida, United States
Sarkis Clinical Trials
🇺🇸Ocala, Florida, United States
Oakland Medical Research Center
🇺🇸Troy, Michigan, United States
Dream Team Clinical Research
🇺🇸Upland, California, United States
Wr-Msra, Llc
🇺🇸Lake City, Florida, United States
Summit Clinical Research, LLC
🇺🇸Athens, Georgia, United States
Christie Clinic
🇺🇸Champaign, Illinois, United States
New Orleans Research Institute
🇺🇸Metairie, Louisiana, United States
IQVIA RDS, Inc.
🇺🇸Cambridge, Massachusetts, United States
Infinite Clinical Trials
🇺🇸Morrow, Georgia, United States
Paragon Rx Clinical, Inc. - Santa Ana
🇺🇸Santa Ana, California, United States
Alternative Solutions, LLC
🇺🇸Saint Petersburg, Florida, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Edward Hines Jr. VA Hospital
🇺🇸Hines, Illinois, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
East View Medical Research, LLC
🇺🇸Mobile, Alabama, United States
Westside Center of Clinical Research
🇺🇸Jacksonville, Florida, United States
New West Physicians
🇺🇸Golden, Colorado, United States
United Medical Doctors
🇺🇸Irvine, California, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Knowledge Research Center
🇺🇸Orange, California, United States
Arkansas Gastroenterology, P.A.
🇺🇸North Little Rock, Arkansas, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
G & L Research
🇺🇸Foley, Alabama, United States
GI Associates of West Alabama, P.C
🇺🇸Tuscaloosa, Alabama, United States
Fomat Medical Research
🇺🇸Camarillo, California, United States
Alliance Research Institute
🇺🇸Canoga Park, California, United States
Alliance Medical Research
🇺🇸Lighthouse Point, Florida, United States
Family Medical Specialists of Florida, PLC
🇺🇸Plant City, Florida, United States
Grand Teton Research Group
🇺🇸Idaho Falls, Idaho, United States
Alliance for Multispecialty Research, LLC
🇺🇸Norman, Oklahoma, United States
Digestive Health Partners, PA
🇺🇸Asheville, North Carolina, United States
Ascension Via Christi Hospitals Wichita, Inc
🇺🇸Wichita, Kansas, United States
The Iowa Clinic, P.C.
🇺🇸West Des Moines, Iowa, United States
Clinical Trials of SWLA, LLC
🇺🇸Lake Charles, Louisiana, United States
Clinical Trials Management, LLC
🇺🇸Metairie, Louisiana, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Northshore Gastroenterology Research, LLC
🇺🇸Westlake, Ohio, United States
Clinical Research Solutions, LLC - TN
🇺🇸Jackson, Tennessee, United States
Rio Grande Gastroenterology
🇺🇸McAllen, Texas, United States
GI Partners of IL / Avicenna
🇺🇸Downers Grove, Illinois, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Digestive Health Specialists, PC
🇺🇸Chelmsford, Massachusetts, United States
Allied Health Clinical Research Organization, LLC
🇺🇸West Long Branch, New Jersey, United States
Mid Hudson Medical Research, PLLC
🇺🇸New Windsor, New York, United States
Coastal Carolina Health Care, P.A
🇺🇸New Bern, North Carolina, United States
Dharma PA D/B/A Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
Sing Chan, MD
🇺🇸Flushing, New York, United States
Gastroenterology Research of San Antonio
🇺🇸San Antonio, Texas, United States
University of Massachusetts - Worcester
🇺🇸Worcester, Massachusetts, United States
Digestive Health Associates
🇺🇸Reno, Nevada, United States
WR-ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Javara
🇺🇸Charlotte, North Carolina, United States
Plains Clinical Research Center, LLC
🇺🇸Fargo, North Dakota, 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
Delta Research Partners
🇺🇸Monroe, Louisiana, United States
Great Lakes Gastroenterology Research, LLC
🇺🇸Mentor, Ohio, United States
Deaconess Clinic, Inc.
🇺🇸Newburgh, Indiana, United States
Clinical Trials of America, LLC
🇺🇸Mount Airy, North Carolina, United States
FMC Science, LLC
🇺🇸Lampasas, Texas, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
A & U Family Medicine
🇺🇸Sugar Land, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
SSM Health Medical Group/Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States
DiGiovanna Institute for Medical Education & Research
🇺🇸North Massapequa, New York, United States
Trial Management Associates, LLC
🇺🇸Wilmington, North Carolina, United States
Spokane Gastroenterology
🇺🇸Spokane, Washington, United States
Paramount Medical Research and Consulting, LLC
🇺🇸Middleburg Heights, Ohio, United States
Wellness Clinical Research
🇺🇸McKinney, Texas, United States
Summit Clinical Research
🇺🇸Petersburg, Virginia, United States
Virginia Gastroenterology Institute
🇺🇸Suffolk, Virginia, United States
Great Lakes Medical Research, LLC
🇺🇸Union City, Tennessee, United States
Care Access Research, Pottsville
🇺🇸Pottsville, Pennsylvania, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Medication Management LLC
🇺🇸Greensboro, North Carolina, United States
Atrium Health Department of Family Medicine Research
🇺🇸Charlotte, North Carolina, United States
Dayton Clinical Research
🇺🇸Dayton, Ohio, United States
META Medical Research Institute, LLC
🇺🇸Dayton, Ohio, United States
Lillestol Research, LLC
🇺🇸Fargo, North Dakota, United States
Texas Tech University Health Sciences Center El Paso
🇺🇸El Paso, Texas, United States
Coastal Research Institute, LLC
🇺🇸Fayetteville, North Carolina, United States
Comprehensive Internal Medicine, Inc
🇺🇸Wooster, Ohio, United States
Progressive Clinical Research, LLC
🇺🇸Bountiful, Utah, United States
Advanced Clinical Research
🇺🇸Riverton, Utah, United States
Granger Medical Clinic
🇺🇸Riverton, Utah, United States
ARC Clinical Research at Kelly Lane
🇺🇸Pflugerville, Texas, United States
Epic Medical Research LLC
🇺🇸Red Oak, Texas, United States
UT MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fairway Medical Clinic
🇺🇸Houston, Texas, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Advanced Research Institute
🇺🇸Sandy, Utah, United States
Digestive System Healthcare
🇺🇸Houston, Texas, United States
Benaroya Research Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Wentachee Valley Hospital
🇺🇸Wenatchee, Washington, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, 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
Central Virginia VA Healthcare System
🇺🇸Richmond, Virginia, United States
Regional GI
🇺🇸Lancaster, Pennsylvania, United States
University Physicians and Surgeons, Inc.(Marshall Health)
🇺🇸Huntington, West Virginia, United States
The Jackson Clinic, PA
🇺🇸Jackson, Tennessee, United States
Blue Ridge Medical Research
🇺🇸Lynchburg, Virginia, United States
Invocare Medical Research & Healthcare Center
🇺🇸West Columbia, South Carolina, United States