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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified July 2023 by Exact Sciences Corporation
Sponsor
Exact Sciences Corporation
Information Provided by (Responsible Party)
Exact Sciences Corporation
Clinicaltrials.gov Identifier
NCT04144738
Other Study ID Numbers:
2019-01
First Submitted
October 27, 2019
First Posted
October 29, 2019
Last Update Posted
August 31, 2023
Last Verified
July 2023

ClinicalTrials.gov processed this data on August 2023. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Colorectal Cancer
Diagnostic Test: mt-sDNA 2.0 screening test

Study Design

Study TypeObservational
Actual Enrollment26758 participants
Official TitleClinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
Study Start DateNovember 14, 2019
Actual Primary Completion DateMarch 29, 2023
Actual Study Completion DateMarch 29, 2023

Groups and Cohorts

Group/CohortIntervention/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.

Outcome Measures

Primary Outcome Measures
  1. Sensitivity for CRC with the mt-sDNA 2.0 test
  2. Specificity with the mt-sDNA 2.0 test
Secondary Outcome Measures
  1. Sensitivity for advanced precancerous lesions
  2. Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT)
  3. Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT).
  4. Specificity for no colorectal neoplastic findings

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
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.

Contacts and Locations

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