Clinical trial NCT04144751: 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"
Official title: 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"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Blood Draw
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 23494
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

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