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Colorectal CancerNCT04144738

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

An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 195 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
mt-sDNA 2.0 screening test, FIT test and Colonoscopy
Type of treatment
Surgery or procedure
How many people
26,758 participants
Where
195 sitesUnited States
Study dates
15 Nov 2019to 30 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • Subjects must meet the following criteria to be eligible for the study:
  • Subject is ≥ 40 years of age at the time of enrollment.
  • Subject presents for a screening colonoscopy per standard of care.
  • Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
  • Subject is able and willing to sign informed consent

Who cannot join

  • Subject has a history of CRC or advanced precancerous lesions.
  • 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.
  • Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
Show all 11Show fewer
  • Subject has a diagnosis of Cronkhite-Canada Syndrome.
  • Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
  • 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.
  • Subject has had overt rectal bleeding within the previous 30 days.
  • Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Trial locations and contacts

195 sites in 1 country.

195 sites in 1 country

United States195 sites

  • Cornerstone Research Institute

    Altamonte Springs, Florida, 32701

  • PMG Research

    Ames, Iowa, 50010

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Gastro Health Research

    Annapolis, Maryland, 21401

  • Digestive Health Partners, PA

    Asheville, North Carolina, 28801

  • Summit Clinical Research, LLC

    Athens, Georgia, 30607

  • Augusta University

    Augusta, Georgia, 30912

  • ARC Clinical Research at Four Points

    Austin, Texas, 78726

  • Elligo Health Research Inc.

    Austin, Texas, 78738

  • ARC Clinical Research at William Cannon

    Austin, Texas, 78745

  • Avant Research Associates

    Austin, Texas, 78748

  • Margaret Mary Health

    Batesville, Indiana, 47006

  • Great Lakes Medical Research, LLC

    Beachwood, Ohio, 44122

  • United Health Services Hospitals, Inc.

    Binghamton, New York, 13903

  • Parkway Medical Center

    Birmingham, Alabama, 35215

  • Summit Internal Medicine, PC

    Birmingham, Alabama, 35243

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center - Harvard

    Boston, Massachusetts, 02215

  • Progressive Clinical Research, LLC

    Bountiful, Utah, 84010

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Connecticut Clinical Research Institute

    Bristol, Connecticut, 06010

  • VA NY Harbor HCS- Brooklyn Campus

    Brooklyn, New York, 11209

  • Fomat Medical Research

    Camarillo, California, 93012

  • IQVIA RDS, Inc.

    Cambridge, Massachusetts, 02139

  • Alliance Research Institute

    Canoga Park, California, 91304

  • Christie Clinic, LLC

    Champaign, Illinois, 61882

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Ralph H. Johnson VAMC

    Charleston, South Carolina, 29401

  • Pharmacorp Clinical Trials, Inc.

    Charleston, South Carolina, 29412

  • Atrium Health Department of Family Medicine Research

    Charlotte, North Carolina, 28207

  • Javara

    Charlotte, North Carolina, 28210

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Digestive Health Specialists, PC

    Chelmsford, Massachusetts, 01824

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • GW Research Inc

    Chula Vista, California, 91910

  • Gastro Health Research

    Cincinnati, Ohio, 45219

  • Hightop Medical Research Clinic

    Cincinnati, Ohio, 45224

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cullman Clinical Trials

    Cullman, Alabama, 35055

  • Mercy Family Clinic

    Dallas, Texas, 75211

  • Dharma PA D/B/A Southwest Family Medicine Associates

    Dallas, Texas, 75235

  • Dayton Clinical Resesarch

    Dayton, Ohio, 45409

  • META Medical Research Institute, LLC

    Dayton, Ohio, 45432

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia, 30033

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36301

  • GI Partners of IL / Avicenna

    Downers Grove, Illinois, 60515

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

  • AGA Clinical Research Associates, LLC

    Egg Harbor, New Jersey, 08234

  • Texas Tech University Health Sciences Center El Paso

    El Paso, Texas, 79905

  • Centennial Medical Group

    Elkridge, Maryland, 21075

  • Horizon Research Group of Opelousas, LLC

    Eunice, Louisiana, 70535

  • Deaconess Clinic, Inc.

    Evansville, Indiana, 47713

  • NECCR PrimaCare Research, LLC

    Fall River, Massachusetts, 02721

  • Lillestol Research, LLC

    Fargo, North Dakota, 58104

  • Plains Clinical Research Center, LLC

    Fargo, North Dakota, 58104

  • Coastal Research Institute, LLC

    Fayetteville, North Carolina, 28304

  • Sing Chan, MD

    Flushing, New York, 11354

  • G & L Research

    Foley, Alabama, 36535

  • Vanguard Clinical Research

    Fort Myers, Florida, 33907

  • Methodist Physicians Clinic / CCT Research

    Fremont, Nebraska, 68025

  • SIMED Health Research

    Gainesville, Florida, 32607

  • Digestive Health Center of the Four States, LLC

    Galena, Kansas, 66739

  • Paragon Rx Clinical, Inc.

    Garden Grove, California, 92840

  • Gastro One

    Germantown, Tennessee, 38138

  • New West Physicians

    Golden, Colorado, 80401

  • Medication Management LLC

    Greensboro, North Carolina, 27405

  • Great Lakes Medical Research, LLC

    Harrisburg, Pennsylvania, 17110

  • Peters Medical Research

    High Point, North Carolina, 27262

  • Edward Hines Jr. VA Hospital

    Hines, Illinois, 60141

  • Houma Digestive Health Specialists-CroNOLA

    Houma, Louisiana, 70360

  • Houston Digestive Disease

    Houston, Texas, 77030

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Fairway Medical Clinic

    Houston, Texas, 77087

  • Digestive System Healthcare

    Houston, Texas, 77505

  • University Physicians and Surgeons, Inc. DBA Marshall Health

    Huntington, West Virginia, 25701

  • Medical Affiliated Research Center

    Huntsville, Alabama, 35801

  • Hutchinson Clinic

    Hutchinson, Kansas, 67502

  • Grand Teton Research Group

    Idaho Falls, Idaho, 83404

  • Richard L. Roudebush VA Medical Center

    Indianapolis, Indiana, 46202

  • University of Iowa

    Iowa City, Iowa, 52242

  • United Medical Doctors

    Irvine, California, 92618

  • Southern Therapy and Advanced Research LLC (STAR)

    Jackson, Mississippi, 39216

  • The Jackson Clinic, PA

    Jackson, Tennessee, 38301

  • Clinical Research Solutions, LLC - TN

    Jackson, Tennessee, 38305

  • The Jackson Clinic, PA

    Jackson, Tennessee, 38305

  • Westside Center of Clinical Research

    Jacksonville, Florida, 32205

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

    Jacksonville, Florida, 32206

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

    Johnstown, Pennsylvania, 15905

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Tri-Cities

    Kingsport, Tennessee, 37663

  • Combined Gastro Research, LLC

    Lafayette, Louisiana, 70503

  • Prime Care Clinical Research Center

    Laguna Hills, California, 92656

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana, 70601

  • Wr-Msra, Llc

    Lake City, Florida, 32055

  • FMC Science, LLC

    Lampasas, Texas, 76550

  • Gastro Care Institute

    Lancaster, California, 93534

  • Regional GI

    Lancaster, Pennsylvania, 17601

  • University of Nevada, Las Vegas

    Las Vegas, Nevada, 89102

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121

  • Tanner Clinic

    Layton, Utah, 84041

  • Pioneer Clinical Research

    Lighthouse PT, Florida, 33064

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53215

  • Rio Grande Gastroenterology

    McAllen, Texas, 78503

  • Wellness Clinical Research

    McKinney, Texas, 75071

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • New Orleans Research Institute

    Metairie, Louisiana, 70006

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • Next Phase Research Alliance

    Miami, Florida, 33144

  • Research Associates of South Florida, LLC

    Miami, Florida, 33156

  • Gastro Health Research

    Miami, Florida, 33176

  • Paramount Medical Research and Consulting, LLC

    Middleburg Heights, Ohio, 44130

  • Ascension Wisconsin

    Milwaukee, Wisconsin, 53211

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • East View Medical Research, LLC

    Mobile, Alabama, 36608

  • Delta Research Partners

    Monroe, Louisiana, 71201

  • Infinite Clinical Trials

    Morrow, Georgia, 30260

  • Clinical Trials of America, LLC

    Mount Airy, North Carolina, 27030

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Coastal Carolina Health Care, P.A.

    New Bern, North Carolina, 28562

  • Yale University

    New Haven, Connecticut, 06519

  • Mid Hudson Medical Research, PLLC

    New Windsor, New York, 12553

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Deaconess Clinic, Inc.

    Newburgh, Indiana, 47630

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma, 73069

  • Arkansas Gastroenterology, P.A.

    North Little Rock, Arkansas, 72117

  • DiGiovanna Institute for Medical Education & Research

    North Massapequa, New York, 11758

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

  • Sarkis Clinical Trials

    Ocala, Florida, 34471

  • Advanced Research Institute

    Ogden, Utah, 84405

  • SSM Health Medical Group/Hightower Clinical

    Oklahoma City, Oklahoma, 73102

  • CHI Nebraska

    Omaha, Nebraska, 68124

  • Knowledge Research Center

    Orange, California, 92868

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California, 92262

  • Imic, Inc.

    Palmetto Bay, Florida, 33157

  • Palo Alto Veterans Institute for Research

    Palo Alto, California, 34304

  • Summit Clinical Research

    Petersburg, Virginia, 23805

  • ARC Clinical Research at Kelly Lane

    Pflugerville, Texas, 78660

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic - AZ

    Phoenix, Arizona, 85054

  • Family Medical Specialists of Florida, PLC

    Plant City, Florida, 33563

  • Care Access Research, Pottsville

    Pottsville, Pennsylvania, 17901

  • Rapid City Medical Center, LLP

    Rapid City, South Dakota, 57701

  • Epic Medical Research, LLC

    Red Oak, Texas, 75154

  • Digestive Health Associates

    Reno, Nevada, 89511

  • Central Virginia VA Healthcare System

    Richmond, Virginia, 23249

  • Advanced Clinical Research

    Riverton, Utah, 84065

  • Granger Medical Clinic

    Riverton, Utah, 84096

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Clinical Associates in Research Therapeutics of America

    San Antonio, Texas, 78212

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229

  • SDG Clinical Research

    San Diego, California, 92103

  • San Jose Gastroenterology

    San Jose, California, 95116

  • Advanced Research Institute

    Sandy City, Utah, 84092

  • Paragon Rx Clinical, Inc. - Santa Ana

    Santa Ana, California, 92703

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101

  • Unison Clinical Trials

    Sherman Oaks, California, 91403

  • Louisiana Research Center; Gastrointestinal Associates

    Shreveport, Louisiana, 71105

  • The South Bend Clinic

    South Bend, Indiana, 46617

  • Spokane Gastroenterology

    Spokane, Washington, 99202

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Alternative Solutions, LLC

    St. Petersburg, Florida, 33711

  • Virginia Gastroenterology Institute

    Suffolk, Virginia, 23434

  • Precision Clinical Research, LLC

    Sunrise, Florida, 33351

  • Clinical Trials of Tampa

    Tampa, Florida, 33614

  • Millennium Clinical Trials

    Thousand Oaks, California, 91360

  • Texas Gastro Consultants

    Tomball, Texas, 77375

  • Oakland Medical Research

    Troy, Michigan, 48085

  • Clinical Research Institute of Michigan, LLC

    Troy, Michigan, 48098

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85712

  • Southern Arizona VA Health Care System (SAVAHCS)

    Tucson, Arizona, 85723

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104

  • GI Associates of West Alabama, P.C

    Tuscaloosa, Alabama, 35406

  • Great Lakes Medical Research, LLC

    Union City, Tennessee, 38261

  • Dream Team Clinical Research

    Upland, California, 91786

  • Wenatchee Valley Hospital

    Wenatchee, Washington, 98801

  • Invocare Medical Research & Healthcare Center

    West Columbia, South Carolina, 29169

  • The Iowa Clinic, P.C.

    West Des Moines, Iowa, 50266

  • Allied Health Clinical Research Organization, LLC

    West Long Branch, New Jersey, 07728

  • Clinical Trials of America, LLC

    West Monroe, Louisiana, 71291

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio, 44145

  • Ascension Via Christi Hospitals Wichita, Inc

    Wichita, Kansas, 67214

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

  • Comprehensive Internal Medicine, Inc

    Wooster, Ohio, 44691

  • University of Massachusetts - Worcester

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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

Read the 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.

Being tested
mt-sDNA 2.0 screening test, FIT test, Colonoscopy
Keywords
Sample Collection, Stool DNA, Colonoscopy
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mt-sDNA 2.0 screening testDiagnostic test

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

  • FIT testDiagnostic test

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

  • ColonoscopyProcedure or surgery

    Subjects will undergo a screening colonoscopy.

Study groups in NCT04144738
Study groupRoleWhat they receive
Individuals eligible for CRC ScreeningIndividuals who are 40 years of age and older, eligible for CRC screening, and scheduled for a screening colonoscopy.
Receives: Diagnostic Test: mt-sDNA 2.0 screening test; Diagnostic Test: FIT test; Procedure: Colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity for CRC with the mt-sDNA 2.0 test

    Measured: Through study completion, an average of 180 days

  2. Specificity with the mt-sDNA 2.0 test

    Measured: Through study completion, an average of 180 days

Secondary outcomes (4)

  1. Sensitivity for advanced precancerous lesions

    Measured: Through study completion, an average of 180 days

  2. Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT)

    Measured: Through study completion, an average of 180 days

  3. Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT).

    Measured: Through study completion, an average of 180 days

  4. Specificity for no colorectal neoplastic findings

    Measured: Through study completion, an average of 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2019
  2. Study start15 Nov 2019
  3. Primary completion30 Mar 2023
  4. Study completion30 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
26,758 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04144738
Sponsor's protocol ID
2019-01
Status last verified
Aug 2023
First submitted
28 Oct 2019
Last updated
1 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Imperiale TF, Gagrat ZD, Krockenberger M, Porter K, Ziegler E, Leduc CM, Matter MB, Olson MC, Limburg PJ. Algorithm Development and Early Performance Evaluation of a Next-Generation Multitarget Stool DNA Screening Test for Colorectal Cancer. Gastro Hep Adv. 2024 May 17;3(6):740-748. doi: 10.1016/j.gastha.2024.05.002. eCollection 2024.

    PubMed 39280922

  • Imperiale TF, Porter K, Zella J, Gagrat ZD, Olson MC, Statz S, Garces J, Lavin PT, Aguilar H, Brinberg D, Berkelhammer C, Kisiel JB, Limburg PJ; BLUE-C Study Investigators. Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):984-993. doi: 10.1056/NEJMoa2310336.

    PubMed 38477986

  • Gagrat ZD, Krockenberger M, Bhattacharya A, Gagrat BZ, Leduc CM, Matter MB, Fourrier KD, Mahoney DW, Edwards V DK, Lidgard GP, Limburg PJ, Johnson SC, Domanico MJ, Kisiel JB. Next-generation Multi-target Stool DNA Panel Accurately Detects Colorectal Cancer and Advanced Precancerous Lesions. Cancer Prev Res (Phila). 2024 Mar 4;17(3):119-126. doi: 10.1158/1940-6207.CAPR-23-0285.

    PubMed 38224564

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 195 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 195 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity for CRC with the mt-sDNA 2.0 test (time frame: Through study completion, an average of 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04144738, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.

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