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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144738
• Other study ID #: 2019-01
• Status: Completed
• Start date: November 15, 2019
• Est. completion date: March 30, 2023

Study information

• Verified date: August 2023
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26758
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• mt-sDNA 2.0 screening test
Stool samples will be collected by the subject for the mt-sDNA screening test.
• FIT test
Stool samples will be collected by the subject for the FIT test.

Procedure:
• Colonoscopy
Subjects will undergo a screening colonoscopy.

Locations

Country	Name	City	State
United States	Cornerstone Research Institute	Altamonte Springs	Florida
United States	PMG Research	Ames	Iowa
United States	University of Michigan	Ann Arbor	Michigan
United States	Gastro Health Research	Annapolis	Maryland
United States	Digestive Health Partners, PA	Asheville	North Carolina
United States	Summit Clinical Research, LLC	Athens	Georgia
United States	Augusta University	Augusta	Georgia
United States	ARC Clinical Research at Four Points	Austin	Texas
United States	ARC Clinical Research at William Cannon	Austin	Texas
United States	Avant Research Associates	Austin	Texas
United States	Elligo Health Research Inc.	Austin	Texas
United States	Margaret Mary Health	Batesville	Indiana
United States	Great Lakes Medical Research, LLC	Beachwood	Ohio
United States	United Health Services Hospitals, Inc.	Binghamton	New York
United States	Parkway Medical Center	Birmingham	Alabama
United States	Summit Internal Medicine, PC	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center - Harvard	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Progressive Clinical Research, LLC	Bountiful	Utah
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Gastroenterology Associates of Fairfield County	Bridgeport	Connecticut
United States	Connecticut Clinical Research Institute	Bristol	Connecticut
United States	VA NY Harbor HCS- Brooklyn Campus	Brooklyn	New York
United States	Fomat Medical Research	Camarillo	California
United States	IQVIA RDS, Inc.	Cambridge	Massachusetts
United States	Alliance Research Institute	Canoga Park	California
United States	Christie Clinic, LLC	Champaign	Illinois
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Pharmacorp Clinical Trials, Inc.	Charleston	South Carolina
United States	Ralph H. Johnson VAMC	Charleston	South Carolina
United States	Atrium Health Department of Family Medicine Research	Charlotte	North Carolina
United States	Javara	Charlotte	North Carolina
United States	WR-ClinSearch, LLC	Chattanooga	Tennessee
United States	Digestive Health Specialists, PC	Chelmsford	Massachusetts
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	GW Research Inc	Chula Vista	California
United States	Gastro Health Research	Cincinnati	Ohio
United States	Hightop Medical Research Clinic	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Cullman Clinical Trials	Cullman	Alabama
United States	Dharma PA D/B/A Southwest Family Medicine Associates	Dallas	Texas
United States	Mercy Family Clinic	Dallas	Texas
United States	Dayton Clinical Resesarch	Dayton	Ohio
United States	META Medical Research Institute, LLC	Dayton	Ohio
United States	Atlanta Center for Gastroenterology, P.C.	Decatur	Georgia
United States	Digestive Health Specialists of the Southeast	Dothan	Alabama
United States	GI Partners of IL / Avicenna	Downers Grove	Illinois
United States	St. Elizabeth Healthcare	Edgewood	Kentucky
United States	AGA Clinical Research Associates, LLC	Egg Harbor Township	New Jersey
United States	Texas Tech University Health Sciences Center El Paso	El Paso	Texas
United States	Centennial Medical Group	Elkridge	Maryland
United States	Horizon Research Group of Opelousas, LLC	Eunice	Louisiana
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	NECCR PrimaCare Research, LLC	Fall River	Massachusetts
United States	Lillestol Research, LLC	Fargo	North Dakota
United States	Plains Clinical Research Center, LLC	Fargo	North Dakota
United States	Coastal Research Institute, LLC	Fayetteville	North Carolina
United States	Sing Chan, MD	Flushing	New York
United States	G & L Research	Foley	Alabama
United States	Vanguard Clinical Research	Fort Myers	Florida
United States	Methodist Physicians Clinic / CCT Research	Fremont	Nebraska
United States	SIMED Health Research	Gainesville	Florida
United States	Digestive Health Center of the Four States, LLC	Galena	Kansas
United States	Paragon Rx Clinical, Inc.	Garden Grove	California
United States	Gastro One	Germantown	Tennessee
United States	New West Physicians	Golden	Colorado
United States	Medication Management LLC	Greensboro	North Carolina
United States	Great Lakes Medical Research, LLC	Harrisburg	Pennsylvania
United States	Peters Medical Research	High Point	North Carolina
United States	Edward Hines Jr. VA Hospital	Hines	Illinois
United States	Houma Digestive Health Specialists-CroNOLA	Houma	Louisiana
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Digestive System Healthcare	Houston	Texas
United States	Fairway Medical Clinic	Houston	Texas
United States	Houston Digestive Disease	Houston	Texas
United States	UT MD Anderson Cancer Center	Houston	Texas
United States	University Physicians and Surgeons, Inc. DBA Marshall Health	Huntington	West Virginia
United States	Medical Affiliated Research Center	Huntsville	Alabama
United States	Hutchinson Clinic	Hutchinson	Kansas
United States	Grand Teton Research Group	Idaho Falls	Idaho
United States	Richard L. Roudebush VA Medical Center	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	United Medical Doctors	Irvine	California
United States	Clinical Research Solutions, LLC - TN	Jackson	Tennessee
United States	Southern Therapy and Advanced Research LLC (STAR)	Jackson	Mississippi
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	Shands Jacksonville Medical Center, Inc - University of Florida Health	Jacksonville	Florida
United States	Westside Center of Clinical Research	Jacksonville	Florida
United States	Richard M. Kastelic, M.D., and Associates, P.C.	Johnstown	Pennsylvania
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Tri-Cities	Kingsport	Tennessee
United States	Combined Gastro Research, LLC	Lafayette	Louisiana
United States	Prime Care Clinical Research Center	Laguna Hills	California
United States	Clinical Trials of SWLA, LLC	Lake Charles	Louisiana
United States	Wr-Msra, Llc	Lake City	Florida
United States	FMC Science, LLC	Lampasas	Texas
United States	Gastro Care Institute	Lancaster	California
United States	Regional GI	Lancaster	Pennsylvania
United States	Clinical Research of South Nevada	Las Vegas	Nevada
United States	University of Nevada, Las Vegas	Las Vegas	Nevada
United States	Tanner Clinic	Layton	Utah
United States	Pioneer Clinical Research	Lighthouse Point	Florida
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Rio Grande Gastroenterology	McAllen	Texas
United States	Wellness Clinical Research	McKinney	Texas
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	New Orleans Research Institute	Metairie	Louisiana
United States	Gastro Health Research	Miami	Florida
United States	Next Phase Research Alliance	Miami	Florida
United States	Research Associates of South Florida, LLC	Miami	Florida
United States	Suncoast Research Group, LLC	Miami	Florida
United States	Paramount Medical Research and Consulting, LLC	Middleburg Heights	Ohio
United States	Ascension Wisconsin	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Facey Medical Foundation	Mission Hills	California
United States	East View Medical Research, LLC	Mobile	Alabama
United States	Delta Research Partners	Monroe	Louisiana
United States	Infinite Clinical Trials	Morrow	Georgia
United States	Clinical Trials of America, LLC	Mount Airy	North Carolina
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Coastal Carolina Health Care, P.A.	New Bern	North Carolina
United States	Yale University	New Haven	Connecticut
United States	Mid Hudson Medical Research, PLLC	New Windsor	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Deaconess Clinic, Inc.	Newburgh	Indiana
United States	Alliance for Multispecialty Research, LLC	Norman	Oklahoma
United States	Arkansas Gastroenterology, P.A.	North Little Rock	Arkansas
United States	DiGiovanna Institute for Medical Education & Research	North Massapequa	New York
United States	Southwest Gastroenterology	Oak Lawn	Illinois
United States	Sarkis Clinical Trials	Ocala	Florida
United States	Advanced Research Institute	Ogden	Utah
United States	SSM Health Medical Group/Hightower Clinical	Oklahoma City	Oklahoma
United States	CHI Nebraska	Omaha	Nebraska
United States	Knowledge Research Center	Orange	California
United States	Desert Oasis Healthcare Medical Group	Palm Springs	California
United States	Imic, Inc.	Palmetto Bay	Florida
United States	Palo Alto Veterans Institute for Research	Palo Alto	California
United States	Summit Clinical Research	Petersburg	Virginia
United States	ARC Clinical Research at Kelly Lane	Pflugerville	Texas
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Mayo Clinic - AZ	Phoenix	Arizona
United States	Family Medical Specialists of Florida, PLC	Plant City	Florida
United States	Care Access Research, Pottsville	Pottsville	Pennsylvania
United States	Rapid City Medical Center, LLP	Rapid City	South Dakota
United States	Epic Medical Research, LLC	Red Oak	Texas
United States	Digestive Health Associates	Reno	Nevada
United States	Central Virginia VA Healthcare System	Richmond	Virginia
United States	Advanced Clinical Research	Riverton	Utah
United States	Granger Medical Clinic	Riverton	Utah
United States	Mayo Clinic	Rochester	Minnesota
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Alternative Solutions, LLC	Saint Petersburg	Florida
United States	Clinical Associates in Research Therapeutics of America	San Antonio	Texas
United States	Gastroenterology Research of San Antonio	San Antonio	Texas
United States	SDG Clinical Research	San Diego	California
United States	San Jose Gastroenterology	San Jose	California
United States	Advanced Research Institute	Sandy	Utah
United States	Paragon Rx Clinical, Inc. - Santa Ana	Santa Ana	California
United States	Sansum Clinic	Santa Barbara	California
United States	Benaroya Research Institute at Virginia Mason	Seattle	Washington
United States	Unison Clinical Trials	Sherman Oaks	California
United States	Louisiana Research Center; Gastrointestinal Associates	Shreveport	Louisiana
United States	The South Bend Clinic	South Bend	Indiana
United States	Spokane Gastroenterology	Spokane	Washington
United States	Virginia Gastroenterology Institute	Suffolk	Virginia
United States	Precision Clinical Research, LLC	Sunrise	Florida
United States	Clinical Trials of Tampa	Tampa	Florida
United States	Millennium Clinical Trials	Thousand Oaks	California
United States	Texas Gastro Consultants	Tomball	Texas
United States	Clinical Research Institute of Michigan, LLC	Troy	Michigan
United States	Oakland Medical Research	Troy	Michigan
United States	Del Sol Research Management, LLC	Tucson	Arizona
United States	Southern Arizona VA Health Care System (SAVAHCS)	Tucson	Arizona
United States	Options Health Research, LLC	Tulsa	Oklahoma
United States	GI Associates of West Alabama, P.C	Tuscaloosa	Alabama
United States	Great Lakes Medical Research, LLC	Union City	Tennessee
United States	Dream Team Clinical Research	Upland	California
United States	Wenatchee Valley Hospital	Wenatchee	Washington
United States	Invocare Medical Research & Healthcare Center	West Columbia	South Carolina
United States	The Iowa Clinic, P.C.	West Des Moines	Iowa
United States	Allied Health Clinical Research Organization, LLC	West Long Branch	New Jersey
United States	Clinical Trials of America, LLC	West Monroe	Louisiana
United States	Northshore Gastroenterology Research, LLC	Westlake	Ohio
United States	Ascension Via Christi Hospitals Wichita, Inc	Wichita	Kansas
United States	Trial Management Associates, LLC	Wilmington	North Carolina
United States	Comprehensive Internal Medicine, Inc	Wooster	Ohio
United States	University of Massachusetts - Worcester	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity for CRC with the mt-sDNA 2.0 test		Through study completion, an average of 180 days
Primary	Specificity with the mt-sDNA 2.0 test		Through study completion, an average of 180 days
Secondary	Sensitivity for advanced precancerous lesions		Through study completion, an average of 180 days
Secondary	Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT)		Through study completion, an average of 180 days
Secondary	Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT).		Through study completion, an average of 180 days
Secondary	Specificity for no colorectal neoplastic findings		Through study completion, an average of 180 days