Clinical trial NCT04144738: Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
Official title: 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: Sample Collection
Stool DNA
Colonoscopy
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 26758
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 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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity for CRC with the mt-sDNA 2.0 test
timeFrame: Through study completion, an average of 180 days
measure: Specificity with the mt-sDNA 2.0 test
timeFrame: Through study completion, an average of 180 days
Secondary outcomes:
measure: Sensitivity for advanced precancerous lesions
timeFrame: Through study completion, an average of 180 days
measure: Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT)
timeFrame: Through study completion, an average of 180 days
measure: Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT).
timeFrame: Through study completion, an average of 180 days
measure: Specificity for no colorectal neoplastic findings
timeFrame: Through study completion, an average of 180 days
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: Pioneer Clinical 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, LLC
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: Batesville
country: United States
facility: Margaret Mary Health
state: Indiana
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center
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
state: Michigan
city: Troy
country: United States
facility: Clinical Research Institute of Michigan, LLC
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 Clinic
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Resesarch
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
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
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: 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: Wenatchee Valley Hospital
state: Washington
city: Huntington
country: United States
facility: University Physicians and Surgeons, Inc. DBA 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: Ascension Wisconsin
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: