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"
1 other identifier
observational
23,494
1 country
194
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Typical duration for all trials
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedStudy Start
First participant enrolled
November 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedSeptember 28, 2023
August 1, 2023
3.4 years
October 28, 2019
September 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood-based biomarkers associated with genetic and epigenetic alterations.
Point in time blood collection (1 day) at enrollment
Study Arms (1)
Subjects Enrolled in 2019-01 BLUE-C
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.
Interventions
Subjects participating in the study will have blood drawn at enrollment.
Eligibility Criteria
Subjects will be men and women, 40 years of age or older, who enroll in Exact Sciences Protocol 2019-01 BLUE-C. Up to 24,000 subjects will be enrolled.
You may qualify if:
- 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.
You may not qualify if:
- \. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (194)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Summit Internal Medicine, PC
Birmingham, Alabama, 35243, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36301, United States
G & L Research
Foley, Alabama, 36535, United States
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
East View Medical Research, LLC
Mobile, Alabama, 36608, United States
GI Associates of West Alabama, P.C
Tuscaloosa, Alabama, 35406, United States
Mayo Clinic - AZ
Phoenix, Arizona, 85054, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85712, United States
Southern Arizona VA Health Care System (SAVAHCS)
Tucson, Arizona, 85723, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
Arkansas Gastroenterology, P.A.
North Little Rock, Arkansas, 72117, United States
Fomat Medical Research
Camarillo, California, 93012, United States
Alliance Research Institute
Canoga Park, California, 91304, United States
GW Research Inc
Chula Vista, California, 91910, United States
Paragon Rx Clinical, Inc.
Garden Grove, California, 92840, United States
United Medical Doctors
Irvine, California, 92618, United States
Prime Care Clinical Research Center
Laguna Hills, California, 92656, United States
Gastro Care Institute
Lancaster, California, 93534, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
Knowledge Research Center
Orange, California, 92868, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Palo Alto Veterans Institute for Research
Palo Alto, California, 34304, United States
SDG Clinical Research
San Diego, California, 92103, United States
San Jose Gastroenterology
San Jose, California, 95116, United States
Paragon Rx Clinical, Inc. - Santa Ana
Santa Ana, California, 92703, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Unison Clinical Trials
Sherman Oaks, California, 91403, United States
Millennium Clinical Trials
Thousand Oaks, California, 91360, United States
Dream Team Clinical Research
Upland, California, 91786, United States
New West Physicians
Golden, Colorado, 80401, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010, United States
Yale University
New Haven, Connecticut, 06519, United States
Cornerstone Research Institute
Altamonte Springs, Florida, 32701, United States
Vanguard Clinical Research
Fort Myers, Florida, 33907, United States
SIMED Health Research
Gainesville, Florida, 32607, United States
Westside Center of Clinical Research
Jacksonville, Florida, 32205, United States
Shands Jacksonville Medical Center, Inc - University of Florida Health
Jacksonville, Florida, 32206, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Wr-Msra, Llc
Lake City, Florida, 32055, United States
Alliance Medical Research
Lighthouse PT, Florida, 33064, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
Next Phase Research Alliance
Miami, Florida, 33144, United States
Research Associates of South Florida, LLC
Miami, Florida, 33156, United States
Gastro Health Research
Miami, Florida, 33176, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Sarkis Clinical Trials
Ocala, Florida, 34471, United States
Imic, Inc.
Palmetto Bay, Florida, 33157, United States
Family Medical Specialists of Florida, PLC
Plant City, Florida, 33563, United States
Alternative Solutions, LLC
St. Petersburg, Florida, 33711, United States
Precision Clinical Research, LLC
Sunrise, Florida, 33351, United States
Clinical Trials of Tampa
Tampa, Florida, 33614, United States
Summit Clinical Research, LLC
Athens, Georgia, 30607, United States
Augusta University
Augusta, Georgia, 30912, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033, United States
Infinite Clinical Trials
Morrow, Georgia, 30260, United States
Grand Teton Research Group
Idaho Falls, Idaho, 83404, United States
Christie Clinic
Champaign, Illinois, 61882, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
GI Partners of IL / Avicenna
Downers Grove, Illinois, 60515, United States
Edward Hines Jr. VA Hospital
Hines, Illinois, 60141, United States
Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
Deaconess Clinic, Inc.
Evansville, Indiana, 47713, United States
Deaconess Clinic, Inc.
Newburgh, Indiana, 47630, United States
The South Bend Clinic
South Bend, Indiana, 46617, United States
PMG Research
Ames, Iowa, 50010, United States
University of Iowa
Iowa City, Iowa, 52242, United States
The Iowa Clinic, P.C.
West Des Moines, Iowa, 50266, United States
Digestive Health Center of the Four States, LLC
Galena, Kansas, 66739, United States
Hutchinson Clinic
Hutchinson, Kansas, 67502, United States
Ascension Via Christi Hospitals Wichita, Inc
Wichita, Kansas, 67214, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Horizon Research Group of Opelousas, LLC
Eunice, Louisiana, 70535, United States
Houma Digestive Health Specialists-CroNOLA
Houma, Louisiana, 70360, United States
Combined Gastro Research. LLC
Lafayette, Louisiana, 70503, United States
Clinical Trials of SWLA, LLC
Lake Charles, Louisiana, 70601, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
New Orleans Research Institute
Metairie, Louisiana, 70006, United States
Delta Research Partners
Monroe, Louisiana, 71201, United States
Louisiana Research Center; Gastrointestinal Associates
Shreveport, Louisiana, 71105, United States
Clinical Trials of America, LLC
West Monroe, Louisiana, 71291, United States
Gastro Health Research
Annapolis, Maryland, 21401, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center - Harvard
Boston, Massachusetts, 02215, United States
IQVIA RDS, Inc.
Cambridge, Massachusetts, 02139, United States
Digestive Health Specialists, PC
Chelmsford, Massachusetts, 01824, United States
NECCR PrimaCare Research, LLC
Fall River, Massachusetts, 02721, United States
University of Massachusetts - Worcester
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Oakland Medical Research Center
Troy, Michigan, 48085, United States
Oakland Medical Research
Troy, Michigan, 48085, United States
Center for Digestive Health Research
Troy, Michigan, 48098, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Southern Therapy and Advanced Research LLC (STAR)
Jackson, Mississippi, 39216, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Methodist Physicians Clinic / CCT Research
Fremont, Nebraska, 68025, United States
CHI Nebraska
Omaha, Nebraska, 68124, United States
University of Nevada, Las Vegas
Las Vegas, Nevada, 89102, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Digestive Health Associates
Reno, Nevada, 89511, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234, United States
Allied Health Clinical Research Organization, LLC
West Long Branch, New Jersey, 07728, United States
United Health Services Hospitals, Inc.
Binghamton, New York, 13903, United States
VA NY Harbor HCS- Brooklyn Campus
Brooklyn, New York, 11209, United States
Sing Chan, MD
Flushing, New York, 11354, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, 12553, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
DiGiovanna Institute for Medical Education & Research
North Massapequa, New York, 11758, United States
Digestive Health Partners, PA
Asheville, North Carolina, 28801, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Atrium Health Department of Family Medicine Research
Charlotte, North Carolina, 28207, United States
Javara
Charlotte, North Carolina, 28210, United States
Coastal Research Institute, LLC
Fayetteville, North Carolina, 28304, United States
Medication Management LLC
Greensboro, North Carolina, 27408, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
Clinical Trials of America, LLC
Mount Airy, North Carolina, 27030, United States
Coastal Carolina Health Care, P.A
New Bern, North Carolina, 28562, United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28403, United States
Lillestol Research, LLC
Fargo, North Dakota, 58104, United States
Plains Clinical Research Center, LLC
Fargo, North Dakota, 58104, United States
Great Lakes Medical Research LLC
Beachwood, Ohio, 44122, United States
Gastro Health Research
Cincinnati, Ohio, 45219, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Dayton Clinical Research
Dayton, Ohio, 45409, United States
META Medical Research Institute, LLC
Dayton, Ohio, 45432, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Paramount Medical Research and Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
Northshore Gastroenterology Research, LLC
Westlake, Ohio, 44145, United States
Comprehensive Internal Medicine, Inc
Wooster, Ohio, 44691, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069, United States
SSM Health Medical Group/Hightower Clinical
Oklahoma City, Oklahoma, 73102, United States
Options Health Research, LLC
Tulsa, Oklahoma, 74104, United States
Great Lakes Medical Research, LLC
Harrisburg, Pennsylvania, 17110, United States
Richard M. Kastelic, M.D., and Associates, P.C.
Johnstown, Pennsylvania, 15905, United States
Regional GI
Lancaster, Pennsylvania, 17601, United States
Thomas Jefferson University Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Care Access Research, Pottsville
Pottsville, Pennsylvania, 17901, United States
Ralph H. Johnson VAMC
Charleston, South Carolina, 29401, United States
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, 29412, United States
Invocare Medical Research & Healthcare Center
West Columbia, South Carolina, 29169, United States
Rapid City Medical Center, LLP
Rapid City, South Dakota, 57701, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Gastro One
Germantown, Tennessee, 38138, United States
The Jackson Clinic, PA
Jackson, Tennessee, 38301, United States
Clinical Research Solutions, LLC - TN
Jackson, Tennessee, 38305, United States
The Jackson Clinic, PA
Jackson, Tennessee, 38305, United States
Tri-Cities Gastroenterology
Kingsport, Tennessee, 37663, United States
Great Lakes Medical Research, LLC
Union City, Tennessee, 38261, United States
ARC Clinical Research at Four Points
Austin, Texas, 78726, United States
Elligo Health Research Inc
Austin, Texas, 78738, United States
ARC Clinical Research at William Cannon
Austin, Texas, 78745, United States
Avant Research Associates
Austin, Texas, 78748, United States
Mercy Family Clinic
Dallas, Texas, 75211, United States
Dharma PA D/B/A Southwest Family Medicine Associates
Dallas, Texas, 75235, United States
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905, United States
Houston Digestive Disease
Houston, Texas, 77030, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Fairway Medical Clinic
Houston, Texas, 77087, United States
Digestive System Healthcare
Houston, Texas, 77505, United States
FMC Science, LLC
Lampasas, Texas, 76550, United States
Rio Grande Gastroenterology
McAllen, Texas, 78503, United States
Wellness Clinical Research
McKinney, Texas, 75071, United States
ARC Clinical Research at Kelly Lane
Pflugerville, Texas, 78660, United States
Epic Medical Research LLC
Red Oak, Texas, 75154, United States
Clinical Associates in Research Therapeutics of America
San Antonio, Texas, 78212, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229, United States
A & U Family Medicine
Sugar Land, Texas, 77479, United States
Texas Gastro Consultants
Tomball, Texas, 77375, United States
Progressive Clinical Research, LLC
Bountiful, Utah, 84010, United States
Tanner Clinic
Layton, Utah, 84041, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Advanced Clinical Research
Riverton, Utah, 84065, United States
Granger Medical Clinic
Riverton, Utah, 84096, United States
Advanced Research Institute
Sandy City, Utah, 84092, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Summit Clinical Research
Petersburg, Virginia, 23805, United States
Central Virginia VA Healthcare System
Richmond, Virginia, 23249, United States
Virginia Gastroenterology Institute
Suffolk, Virginia, 23434, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101, United States
Spokane Gastroenterology
Spokane, Washington, 99202, United States
Wentachee Valley Hospital
Wenatchee, Washington, 98801, United States
University Physicians and Surgeons, Inc.(Marshall Health)
Huntington, West Virginia, 25701, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53215, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
Biospecimen
Blood samples may be used for evaluating performance of biomarkers for feasibility and assay development. Sample may be stored for up to 20 years. These blood samples will be de-identified.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Imperiale, MD
Indiana University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2019
First Posted
October 30, 2019
Study Start
November 15, 2019
Primary Completion
March 30, 2023
Study Completion
March 30, 2023
Last Updated
September 28, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data may be available from 2 years and ending 4 years after publication.
- Access Criteria
- Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research.
Individual participant data that underlie the results reported in publications of the study may be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol and informed consent form may also be shared. Data may be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.