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

The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: mt-sDNA 2.0 screening test; Diagnostic test: FIT test; Procedure: Colonoscopy

Detailed Description

Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subject will complete the mt-sDNA 2.0 test and the commercially available FIT, followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test and FIT will not be provided to investigators for clinical management of the study subject. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathologial review of reports or tissue (if applicable) will remain blinded to the results of the mt-sDNA 2.0 screening test results.

• Study Type: Observational
• Enrollment (Actual): 26758

Contacts and Locations

• Study Contact: Name: Marla Kuleszynski; Phone Number: 608-400-3569; Email: mkuleszynski@exactsciences.com
• Study Contact Backup: Name: Dania Brooks; Phone Number: 608-293-3437; Email: dbrooks@exactsciences.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35215
      • Parkway Medical Center
    • Birmingham, Alabama, United States, 35243
      • Summit Internal Medicine, PC
    • Cullman, Alabama, United States, 35055
      • Cullman Clinical Trials
    • Dothan, Alabama, United States, 36301
      • Digestive Health Specialists of the Southeast
    • Foley, Alabama, United States, 36535
      • G & L Research
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center
    • Mobile, Alabama, United States, 36608
      • East View Medical Research, LLC
    • Tuscaloosa, Alabama, United States, 35406
      • GI Associates of West Alabama, P.C
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic - AZ
    • Tucson, Arizona, United States, 85712
      • Del Sol Research Management, LLC
    • Tucson, Arizona, United States, 85723
      • Southern Arizona VA Health Care System (SAVAHCS)
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Lynn Institute of the Ozarks
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Gastroenterology, P.A.
  • California
    • Camarillo, California, United States, 93012
      • FOMAT Medical Research
    • Canoga Park, California, United States, 91304
      • Alliance Research Institute
    • Chula Vista, California, United States, 91910
      • GW Research Inc
    • Garden Grove, California, United States, 92840
      • Paragon Rx Clinical, Inc.
    • Irvine, California, United States, 92618
      • United Medical Doctors
    • Laguna Hills, California, United States, 92656
      • Prime Care Clinical Research Center
    • Lancaster, California, United States, 93534
      • Gastro Care Institute
    • Mission Hills, California, United States, 91345
      • Facey Medical Foundation
    • Orange, California, United States, 92868
      • Knowledge Research Center
    • Palm Springs, California, United States, 92262
      • Desert Oasis Healthcare Medical Group
    • Palo Alto, California, United States, 34304
      • Palo Alto Veterans Institute for Research
    • San Diego, California, United States, 92103
      • SDG Clinical Research
    • San Jose, California, United States, 95116
      • San Jose Gastroenterology
    • Santa Ana, California, United States, 92703
      • Paragon Rx Clinical, Inc. - Santa Ana
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic
    • Sherman Oaks, California, United States, 91403
      • Unison Clinical Trials
    • Thousand Oaks, California, United States, 91360
      • Millennium Clinical Trials
    • Upland, California, United States, 91786
      • Dream Team Clinical Research
  • Colorado
    • Golden, Colorado, United States, 80401
      • New West Physicians
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
    • Bridgeport, Connecticut, United States, 06606
      • Gastroenterology Associates of Fairfield County
    • Bristol, Connecticut, United States, 06010
      • Connecticut Clinical Research Institute
    • New Haven, Connecticut, United States, 06519
      • Yale University
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Cornerstone Research Institute
    • Fort Myers, Florida, United States, 33907
      • Vanguard Clinical Research
    • Gainesville, Florida, United States, 32607
      • SIMED Health Research
    • Jacksonville, Florida, United States, 32205
      • Westside Center of Clinical Research
    • Jacksonville, Florida, United States, 32206
      • Shands Jacksonville Medical Center, Inc - University of Florida Health
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Lake City, Florida, United States, 32055
      • Wr-Msra, Llc
    • Lighthouse Point, Florida, United States, 33064
      • Pioneer Clinical Research
    • Miami, Florida, United States, 33156
      • Research Associates of South Florida, LLC
    • Miami, Florida, United States, 33144
      • Next Phase Research Alliance
    • Miami, Florida, United States, 33135
      • Suncoast Research Group, LLC
    • Miami, Florida, United States, 33176
      • Gastro Health Research
    • Naples, Florida, United States, 34102
      • Gastroenterology Group of Naples
    • Ocala, Florida, United States, 34471
      • Sarkis Clinical Trials
    • Palmetto Bay, Florida, United States, 33157
      • IMIC, Inc.
    • Plant City, Florida, United States, 33563
      • Family Medical Specialists of Florida, PLC
    • Saint Petersburg, Florida, United States, 33711
      • Alternative Solutions, LLC
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research, LLC
    • Tampa, Florida, United States, 33614
      • Clinical Trials of Tampa
  • Georgia
    • Athens, Georgia, United States, 30607
      • Summit Clinical Research, LLC
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Decatur, Georgia, United States, 30033
      • Atlanta Center for Gastroenterology, P.C.
    • Morrow, Georgia, United States, 30260
      • Infinite Clinical Trials
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Grand Teton Research Group
  • Illinois
    • Champaign, Illinois, United States, 61882
      • Christie Clinic, LLC
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Downers Grove, Illinois, United States, 60515
      • GI Partners of IL / Avicenna
    • Hines, Illinois, United States, 60141
      • Edward Hines Jr. VA Hospital
    • Oak Lawn, Illinois, United States, 60453
      • Southwest Gastroenterology
  • Indiana
    • Batesville, Indiana, United States, 47006
      • Margaret Mary Health
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic, Inc.
    • Indianapolis, Indiana, United States, 46202
      • Richard L. Roudebush VA Medical Center
    • Newburgh, Indiana, United States, 47630
      • Deaconess Clinic, Inc.
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic
  • Iowa
    • Ames, Iowa, United States, 50010
      • PMG Research
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic, P.C.
  • Kansas
    • Galena, Kansas, United States, 66739
      • Digestive Health Center of the Four States, LLC
    • Hutchinson, Kansas, United States, 67502
      • Hutchinson Clinic
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi Hospitals Wichita, Inc
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Healthcare
  • Louisiana
    • Eunice, Louisiana, United States, 70535
      • Horizon Research Group of Opelousas, LLC
    • Houma, Louisiana, United States, 70360
      • Houma Digestive Health Specialists-CroNOLA
    • Lafayette, Louisiana, United States, 70503
      • Combined Gastro Research, LLC
    • Lake Charles, Louisiana, United States, 70601
      • Clinical Trials of SWLA, LLC
    • Metairie, Louisiana, United States, 70006
      • New Orleans Research Institute
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management, LLC
    • Monroe, Louisiana, United States, 71201
      • Delta Research Partners
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center; Gastrointestinal Associates
    • West Monroe, Louisiana, United States, 71291
      • Clinical Trials of America, LLC
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Gastro Health Research
    • Chevy Chase, Maryland, United States, 20815
      • Chevy Chase Clinical Research
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center - Harvard
    • Cambridge, Massachusetts, United States, 02139
      • IQVIA RDS, Inc.
    • Chelmsford, Massachusetts, United States, 01824
      • Digestive Health Specialists, PC
    • Fall River, Massachusetts, United States, 02721
      • NECCR PrimaCare Research, LLC
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts - Worcester
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Troy, Michigan, United States, 48098
      • Clinical Research Institute of Michigan, LLC
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Southern Therapy and Advanced Research LLC (STAR)
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Methodist Physicians Clinic / CCT Research
    • Omaha, Nebraska, United States, 68124
      • CHI Nebraska
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Clinical Research of South Nevada
    • Las Vegas, Nevada, United States, 89102
      • University of Nevada, Las Vegas
    • Reno, Nevada, United States, 89511
      • Digestive Health Associates
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • AGA Clinical Research Associates, LLC
    • West Long Branch, New Jersey, United States, 07728
      • Allied Health Clinical Research Organization, LLC
  • New York
    • Binghamton, New York, United States, 13903
      • United Health Services Hospitals, Inc.
    • Brooklyn, New York, United States, 11209
      • VA NY Harbor HCS- Brooklyn Campus
    • Flushing, New York, United States, 11354
      • Sing Chan, MD
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research, PLLC
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • North Massapequa, New York, United States, 11758
      • DiGiovanna Institute for Medical Education & Research
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Digestive Health Partners, PA
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28210
      • Javara
    • Charlotte, North Carolina, United States, 28207
      • Atrium Health Department of Family Medicine Research
    • Fayetteville, North Carolina, United States, 28304
      • Coastal Research Institute, LLC
    • Greensboro, North Carolina, United States, 27405
      • Medication Management LLC
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research
    • Mount Airy, North Carolina, United States, 27030
      • Clinical Trials of America, LLC
    • New Bern, North Carolina, United States, 28562
      • Coastal Carolina Health Care, P.A.
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates, LLC
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Clinical Research Center, LLC
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research, LLC
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Great Lakes Medical Research, LLC
    • Cincinnati, Ohio, United States, 45224
      • Hightop Medical Research Clinic
    • Cincinnati, Ohio, United States, 45219
      • Gastro Health Research
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Dayton, Ohio, United States, 45432
      • META Medical Research Institute, LLC
    • Dayton, Ohio, United States, 45409
      • Dayton Clinical Resesarch
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology Research, LLC
    • Middleburg Heights, Ohio, United States, 44130
      • Paramount Medical Research and Consulting, Llc
    • Westlake, Ohio, United States, 44145
      • Northshore Gastroenterology Research, LLC
    • Wooster, Ohio, United States, 44691
      • Comprehensive Internal Medicine, Inc
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Alliance for Multispecialty Research, LLC
    • Oklahoma City, Oklahoma, United States, 73102
      • SSM Health Medical Group/Hightower Clinical
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research, LLC
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17110
      • Great Lakes Medical Research, LLC
    • Johnstown, Pennsylvania, United States, 15905
      • Richard M. Kastelic, M.D., and Associates, P.C.
    • Lancaster, Pennsylvania, United States, 17601
      • Regional GI
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pottsville, Pennsylvania, United States, 17901
      • Care Access Research, Pottsville
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Pharmacorp Clinical Trials, Inc.
    • Charleston, South Carolina, United States, 29401
      • Ralph H. Johnson VAMC
    • West Columbia, South Carolina, United States, 29169
      • Invocare Medical Research & Healthcare Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Medical Center, LLP
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • WR-Clinsearch, LLC
    • Germantown, Tennessee, United States, 38138
      • Gastro One
    • Jackson, Tennessee, United States, 38301
      • The Jackson Clinic, PA
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic, PA
    • Jackson, Tennessee, United States, 38305
      • Clinical Research Solutions, LLC - TN
    • Kingsport, Tennessee, United States, 37663
      • Tri-Cities
    • Union City, Tennessee, United States, 38261
      • Great Lakes Medical Research, LLC
  • Texas
    • Austin, Texas, United States, 78745
      • ARC Clinical Research at William Cannon
    • Austin, Texas, United States, 78726
      • ARC Clinical Research at Four Points
    • Austin, Texas, United States, 78748
      • Avant Research Associates
    • Austin, Texas, United States, 78738
      • Elligo Health Research Inc.
    • Dallas, Texas, United States, 75211
      • Mercy Family Clinic
    • Dallas, Texas, United States, 75235
      • Dharma PA D/B/A Southwest Family Medicine Associates
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center El Paso
    • Houston, Texas, United States, 77030
      • UT MD Anderson Cancer Center
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, Llc
    • Houston, Texas, United States, 77030
      • Houston Digestive Disease
    • Houston, Texas, United States, 77087
      • Fairway Medical Clinic
    • Houston, Texas, United States, 77505
      • Digestive System Healthcare
    • Lampasas, Texas, United States, 76550
      • Fmc Science, Llc
    • McAllen, Texas, United States, 78503
      • Rio Grande Gastroenterology
    • McKinney, Texas, United States, 75071
      • Wellness Clinical Research
    • Pflugerville, Texas, United States, 78660
      • ARC Clinical Research at Kelly Lane
    • Red Oak, Texas, United States, 75154
      • Epic Medical Research, LLC
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Research of San Antonio
    • San Antonio, Texas, United States, 78212
      • Clinical Associates in Research Therapeutics of America
    • Tomball, Texas, United States, 77375
      • Texas Gastro Consultants
  • Utah
    • Bountiful, Utah, United States, 84010
      • Progressive Clinical Research, LLC
    • Layton, Utah, United States, 84041
      • Tanner Clinic
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
    • Riverton, Utah, United States, 84096
      • Granger Medical Clinic
    • Riverton, Utah, United States, 84065
      • Advanced Clinical Research
    • Sandy, Utah, United States, 84092
      • Advanced Research Institute
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Blue Ridge Medical Research
    • Petersburg, Virginia, United States, 23805
      • Summit Clinical Research
    • Richmond, Virginia, United States, 23249
      • Central Virginia VA Healthcare System
    • Suffolk, Virginia, United States, 23434
      • Virginia Gastroenterology Institute
  • Washington
    • Seattle, Washington, United States, 98101
      • Benaroya Research Institute at Virginia Mason
    • Spokane, Washington, United States, 99202
      • Spokane Gastroenterology
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • University Physicians and Surgeons, Inc. DBA Marshall Health
  • Wisconsin
    • Madison, Wisconsin, United States, 53215
      • University of Wisconsin Hospital and Clinics
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research
    • Milwaukee, Wisconsin, United States, 53211
      • Ascension Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects 40 years of age and older who are eligible for CRC screening and scheduled for a screening colonoscopy. 24,000 subjects are targeted to enroll.

Description

Inclusion Criteria:

Subjects must meet the following criteria to be eligible for the study:

1. Subject is ≥ 40 years of age at the time of enrollment.
2. Subject presents for a screening colonoscopy per standard of care.
3. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
4. Subject is able and willing to sign informed consent

Exclusion Criteria:

1. Subject has a history of CRC or advanced precancerous lesions.

2. Subject has a diagnosis or medical / family history of any of the following conditions, including:

   • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
   • Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
   • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
3. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
4. Subject has a diagnosis of Cronkhite-Canada Syndrome.
5. Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
6. Subject has undergone a colonoscopy within the previous 9 years with the exception of a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
7. Subject has had overt rectal bleeding within the previous 30 days.
8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals eligible for CRC Screening; Individuals who are 40 years of age and older, eligible for CRC screening, and scheduled for a screening colonoscopy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity for CRC with the mt-sDNA 2.0 test	Through study completion, an average of 180 days
Specificity with the mt-sDNA 2.0 test	Through study completion, an average of 180 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity for advanced precancerous lesions	Through study completion, an average of 180 days
Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT)	Through study completion, an average of 180 days
Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT).	Through study completion, an average of 180 days
Specificity for no colorectal neoplastic findings	Through study completion, an average of 180 days

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation
• Investigators: Principal Investigator: Thomas Imperiale, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Colonoscopy; Sample Collection; Stool DNA
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2019-01 (Other Identifier: NANT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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, statistical analysis plan, 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.
• IPD Sharing Time Frame: Data may be available from 2 years and ending 4 years after publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No