"Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening BLUE-C"

CompletedOBSERVATIONAL
Enrollment

26,758

Participants

Timeline

Start Date

November 15, 2019

Primary Completion Date

March 30, 2023

Study Completion Date

March 30, 2023

Conditions
Colorectal Cancer
Interventions
DIAGNOSTIC_TEST

mt-sDNA 2.0 screening test

Stool samples will be collected by the subject for the mt-sDNA screening test.

DIAGNOSTIC_TEST

FIT test

Stool samples will be collected by the subject for the FIT test.

PROCEDURE

Colonoscopy

Subjects will undergo a screening colonoscopy.

Trial Locations (195)

10029

Icahn School of Medicine at Mount Sinai, New York

11209

VA NY Harbor HCS- Brooklyn Campus, Brooklyn

11354

Sing Chan, MD, Flushing

11758

DiGiovanna Institute for Medical Education & Research, North Massapequa

12553

Mid Hudson Medical Research, PLLC, New Windsor

13903

United Health Services Hospitals, Inc., Binghamton

15905

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

17110

Great Lakes Medical Research, LLC, Harrisburg

17601

Regional GI, Lancaster

17901

Care Access Research, Pottsville, Pottsville

19107

Thomas Jefferson University, Philadelphia

20815

Chevy Chase Clinical Research, Chevy Chase

21075

Centennial Medical Group, Elkridge

21401

Gastro Health Research, Annapolis

23249

Central Virginia VA Healthcare System, Richmond

23434

Virginia Gastroenterology Institute, Suffolk

23805

Summit Clinical Research, Petersburg

24502

Blue Ridge Medical Research, Lynchburg

25701

University Physicians and Surgeons, Inc. DBA Marshall Health, Huntington

27030

Clinical Trials of America, LLC, Mount Airy

27262

Peters Medical Research, High Point

27405

Medication Management LLC, Greensboro

27599

University of North Carolina at Chapel Hill, Chapel Hill

28207

Atrium Health Department of Family Medicine Research, Charlotte

28210

Javara, Charlotte

28304

Coastal Research Institute, LLC, Fayetteville

28403

Trial Management Associates, LLC, Wilmington

28562

Coastal Carolina Health Care, P.A., New Bern

28801

Digestive Health Partners, PA, Asheville

29169

Invocare Medical Research & Healthcare Center, West Columbia

29401

Ralph H. Johnson VAMC, Charleston

29412

Pharmacorp Clinical Trials, Inc., Charleston

30033

Atlanta Center for Gastroenterology, P.C., Decatur

30260

Infinite Clinical Trials, Morrow

30607

Summit Clinical Research, LLC, Athens

30912

Augusta University, Augusta

32055

Wr-Msra, Llc, Lake City

32205

Westside Center of Clinical Research, Jacksonville

32206

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

32607

SIMED Health Research, Gainesville

32701

Cornerstone Research Institute, Altamonte Springs

33064

Pioneer Clinical Research, Lighthouse PT

33135

Suncoast Research Group, LLC, Miami

33144

Next Phase Research Alliance, Miami

33156

Research Associates of South Florida, LLC, Miami

33157

Imic, Inc., Palmetto Bay

33176

Gastro Health Research, Miami

33351

Precision Clinical Research, LLC, Sunrise

33458

Health Awareness, Inc., Jupiter

33563

Family Medical Specialists of Florida, PLC, Plant City

33614

Clinical Trials of Tampa, Tampa

33711

Alternative Solutions, LLC, St. Petersburg

33907

Vanguard Clinical Research, Fort Myers

34102

Gastroenterology Group of Naples, Naples

34304

Palo Alto Veterans Institute for Research, Palo Alto

34471

Sarkis Clinical Trials, Ocala

35055

Cullman Clinical Trials, Cullman

35215

Parkway Medical Center, Birmingham

35243

Summit Internal Medicine, PC, Birmingham

35294

University of Alabama at Birmingham, Birmingham

35406

GI Associates of West Alabama, P.C, Tuscaloosa

35801

Medical Affiliated Research Center, Huntsville

36301

Digestive Health Specialists of the Southeast, Dothan

36535

G & L Research, Foley

36608

East View Medical Research, LLC, Mobile

37421

WR-ClinSearch, LLC, Chattanooga

37663

Tri-Cities, Kingsport

38138

Gastro One, Germantown

38261

Great Lakes Medical Research, LLC, Union City

38301

The Jackson Clinic, PA, Jackson

38305

Clinical Research Solutions, LLC - TN, Jackson

The Jackson Clinic, PA, Jackson

39216

Southern Therapy and Advanced Research LLC (STAR), Jackson

41017

St. Elizabeth Healthcare, Edgewood

44060

Great Lakes Gastroenterology Research, LLC, Mentor

44106

University Hospitals Cleveland Medical Center, Cleveland

44122

Great Lakes Medical Research, LLC, Beachwood

44130

Paramount Medical Research and Consulting, LLC, Middleburg Heights

44145

Northshore Gastroenterology Research, LLC, Westlake

44691

Comprehensive Internal Medicine, Inc, Wooster

45219

Gastro Health Research, Cincinnati

45224

Hightop Medical Research Clinic, Cincinnati

45409

Dayton Clinical Resesarch, Dayton

45432

META Medical Research Institute, LLC, Dayton

46202

Richard L. Roudebush VA Medical Center, Indianapolis

46617

The South Bend Clinic, South Bend

47006

Margaret Mary Health, Batesville

47630

Deaconess Clinic, Inc., Newburgh

47713

Deaconess Clinic, Inc., Evansville

48085

Oakland Medical Research, Troy

48098

Clinical Research Institute of Michigan, LLC, Troy

48109

University of Michigan, Ann Arbor

50010

PMG Research, Ames

50266

The Iowa Clinic, P.C., West Des Moines

52242

University of Iowa, Iowa City

53211

Ascension Wisconsin, Milwaukee

53215

University of Wisconsin Hospital and Clinics, Madison

Wisconsin Center for Advanced Research, Milwaukee

55905

Mayo Clinic, Rochester

57701

Rapid City Medical Center, LLP, Rapid City

58104

Lillestol Research, LLC, Fargo

Plains Clinical Research Center, LLC, Fargo

60141

Edward Hines Jr. VA Hospital, Hines

60453

Southwest Gastroenterology, Oak Lawn

60515

GI Partners of IL / Avicenna, Downers Grove

60612

Rush University Medical Center, Chicago

61882

Christie Clinic, LLC, Champaign

63005

Clinical Research Professionals, Chesterfield

63141

Sundance Clinical Research, LLC, St Louis

66739

Digestive Health Center of the Four States, LLC, Galena

67214

Ascension Via Christi Hospitals Wichita, Inc, Wichita

67502

Hutchinson Clinic, Hutchinson

68025

Methodist Physicians Clinic / CCT Research, Fremont

68124

CHI Nebraska, Omaha

70006

Clinical Trials Management, LLC, Metairie

New Orleans Research Institute, Metairie

70360

Houma Digestive Health Specialists-CroNOLA, Houma

70503

Combined Gastro Research, LLC, Lafayette

70535

Horizon Research Group of Opelousas, LLC, Eunice

70601

Clinical Trials of SWLA, LLC, Lake Charles

71105

Louisiana Research Center; Gastrointestinal Associates, Shreveport

71201

Delta Research Partners, Monroe

71291

Clinical Trials of America, LLC, West Monroe

72117

Arkansas Gastroenterology, P.A., North Little Rock

72204

Lynn Institute of the Ozarks, Little Rock

72212

Applied Research Center of Arkansas, Little Rock

73069

Alliance for Multispecialty Research, LLC, Norman

73102

SSM Health Medical Group/Hightower Clinical, Oklahoma City

74104

Options Health Research, LLC, Tulsa

75071

Wellness Clinical Research, McKinney

75154

Epic Medical Research, LLC, Red Oak

75211

Mercy Family Clinic, Dallas

75235

Dharma PA D/B/A Southwest Family Medicine Associates, Dallas

76550

FMC Science, LLC, Lampasas

77030

Houston Digestive Disease, Houston

UT MD Anderson Cancer Center, Houston

77084

Biopharma Informatic, LLC, Houston

77087

Fairway Medical Clinic, Houston

77375

Texas Gastro Consultants, Tomball

77505

Digestive System Healthcare, Houston

78212

Clinical Associates in Research Therapeutics of America, San Antonio

78229

Gastroenterology Research of San Antonio, San Antonio

78503

Rio Grande Gastroenterology, McAllen

78660

ARC Clinical Research at Kelly Lane, Pflugerville

78726

ARC Clinical Research at Four Points, Austin

78738

Elligo Health Research Inc., Austin

78745

ARC Clinical Research at William Cannon, Austin

78748

Avant Research Associates, Austin

79905

Texas Tech University Health Sciences Center El Paso, El Paso

80401

New West Physicians, Golden

83404

Grand Teton Research Group, Idaho Falls

84010

Progressive Clinical Research, LLC, Bountiful

84041

Tanner Clinic, Layton

84065

Advanced Clinical Research, Riverton

84092

Advanced Research Institute, Sandy City

84096

Granger Medical Clinic, Riverton

84405

Advanced Research Institute, Ogden

85054

Mayo Clinic - AZ, Phoenix

85712

Del Sol Research Management, LLC, Tucson

85723

Southern Arizona VA Health Care System (SAVAHCS), Tucson

89102

University of Nevada, Las Vegas, Las Vegas

89121

Clinical Research of South Nevada, Las Vegas

89511

Digestive Health Associates, Reno

91304

Alliance Research Institute, Canoga Park

91345

Facey Medical Foundation, Mission Hills

91360

Millennium Clinical Trials, Thousand Oaks

91403

Unison Clinical Trials, Sherman Oaks

91786

Dream Team Clinical Research, Upland

91910

GW Research Inc, Chula Vista

92103

SDG Clinical Research, San Diego

92262

Desert Oasis Healthcare Medical Group, Palm Springs

92618

United Medical Doctors, Irvine

92656

Prime Care Clinical Research Center, Laguna Hills

92703

Paragon Rx Clinical, Inc. - Santa Ana, Santa Ana

92840

Paragon Rx Clinical, Inc., Garden Grove

92868

Knowledge Research Center, Orange

93012

Fomat Medical Research, Camarillo

93105

Sansum Clinic, Santa Barbara

93534

Gastro Care Institute, Lancaster

95116

San Jose Gastroenterology, San Jose

98101

Benaroya Research Institute at Virginia Mason, Seattle

98801

Wenatchee Valley Hospital, Wenatchee

99202

Spokane Gastroenterology, Spokane

06606

Gastroenterology Associates of Fairfield County, Bridgeport

06610

Bridgeport Hospital, Bridgeport

06010

Connecticut Clinical Research Institute, Bristol

06519

Yale University, New Haven

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center - Harvard, Boston

02139

IQVIA RDS, Inc., Cambridge

01824

Digestive Health Specialists, PC, Chelmsford

02721

NECCR PrimaCare Research, LLC, Fall River

01655

University of Massachusetts - Worcester, Worcester

08234

AGA Clinical Research Associates, LLC, Egg Harbor

07728

Allied Health Clinical Research Organization, LLC, West Long Branch

Sponsors
All Listed Sponsors
lead

Exact Sciences Corporation

INDUSTRY