An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now

Completed

Conditions: Colorectal Cancer

Interventions: Diagnostic Test: mt-sDNA screening test
Procedure: Colonoscopy

Registration Number: NCT03728348

Lead Sponsor: Exact Sciences Corporation

Brief Summary: The primary objective is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49.

Detailed Description: Subjects aged 45-49 at average risk for development of CRC will be enrolled. Subjects will complete the mt-sDNA screening test (Cologuard) followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test (Cologuard) will not be provided to investigators for clinical management of study subjects. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathological review of tissue (if applicable) will remain blinded to the results of the mt-sDNA screening test (Cologuard) result.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 983

Inclusion Criteria

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

Subject is at average risk for development of CRC.
Subject is able and willing to undergo a screening colonoscopy.
Subject is ≥ 45 and ≤ 49 years of age at the time of enrollment.
Subject is willing and able to sign informed consent.
Subject is able and willing to provide stool sample(s) according to written instructions provided.

Exclusion Criteria

Subject has a history of CRC or adenoma.
Subject has ≥2 first-degree relatives who have been diagnosed with CRC
Subject has one first-degree relative with CRC diagnosed before the age of 60.
Subject has any of the following: Overt rectal bleeding, e.g., hematochezia or melena within the previous 30 days (blood on toilet paper, after wiping, does not constitute rectal bleeding). Positive fecal occult blood test or FIT within the previous six (6) months. Subject has had a previous colonoscopy. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
Subject has a diagnosis or personal 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 and Familial Hyperplastic Polyposis.
Subject has a family history of: Familial adenomatous polyposis (also referred to as "FAP"), Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
Subjects with Cronkhite-Canada Syndrome.
Subject has a diagnosis of inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
Subject has a history of aerodigestive tract cancer.
Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
Subject has any condition that in the opinion of the investigator should preclude participation in the study.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subject aged 45-49 with Average CRC Risk	Colonoscopy	Subject aged 45-49 with average risk for development of CRC.
Subject aged 45-49 with Average CRC Risk	mt-sDNA screening test	Subject aged 45-49 with average risk for development of CRC.

Primary Outcome Measures

Name	Time	Method
Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49	Through study completion, an average of 60 days	An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Specificity =100\*(multi-target stool DNA test negative/negative colonoscopy)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (39): Gastroenterology Associates of Fairfield County
🇺🇸
Bridgeport, Connecticut, United States
Asheville Gastroenterology Associates
🇺🇸
Asheville, North Carolina, United States
DM Clinical Research- PCP for Life
🇺🇸
Houston, Texas, United States
Indiana University, Eskanazi Hospital
🇺🇸
Indianapolis, Indiana, United States
Quality Medical Research, PLLC
🇺🇸
Nashville, Tennessee, United States
Mayo Clinic Arizona
🇺🇸
Phoenix, Arizona, United States
Delta Research Partners, LLC
🇺🇸
Monroe, Louisiana, United States
Investigative Clinical Research
🇺🇸
Annapolis, Maryland, United States
Wilmington Gastroenterology Associates
🇺🇸
Wilmington, North Carolina, United States
United Medical Associates
🇺🇸
Binghamton, New York, United States
Alliance Research Centers
🇺🇸
Laguna Hills, California, United States
DM Clinical Research- Southwest Gastroenterology
🇺🇸
Oak Lawn, Illinois, United States
Louisiana Research Center
🇺🇸
Shreveport, Louisiana, United States
Comprehensive Internal Medicine, Inc.
🇺🇸
Wooster, Ohio, United States
Commonwealth Clinical Studies
🇺🇸
Brockton, Massachusetts, United States
Charlotte Gastroenterology & Hepatology, PLLC
🇺🇸
Charlotte, North Carolina, United States
Precision Clinical Research, LLC
🇺🇸
Lauderdale Lakes, Florida, United States
Deaconess Clinic- Gateway
🇺🇸
Newburgh, Indiana, United States
Centennial Medical Group
🇺🇸
Elkridge, Maryland, United States
Northshore University Health System Evanston Hospital
🇺🇸
Evanston, Illinois, United States
Great Lakes Gastroenterology Research, LLC
🇺🇸
Mentor, Ohio, United States
Gastro One
🇺🇸
Germantown, Tennessee, United States
Focilmed
🇺🇸
Oxnard, California, United States
Desert Oasis Healthcare Medical Group
🇺🇸
Palm Springs, California, United States
Deaconess Clinic- Mt. Pleasant
🇺🇸
Evansville, Indiana, United States
Johnson County ClinTrials, LLC
🇺🇸
Lenexa, Kansas, United States
New Orleans Research Institute
🇺🇸
Metairie, Louisiana, United States
Capitol Research
🇺🇸
Rockville, Maryland, United States
Ventura County Gastroenterology
🇺🇸
Camarillo, California, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
Gastroenterology Associates, PA
🇺🇸
Greenville, South Carolina, United States
University of Texas Health Science Center- McGovern Medical School
🇺🇸
Houston, Texas, United States
Family Practice Center of Wooster, Inc./Clinical Trial Developers
🇺🇸
Massillon, Ohio, United States
Virginia Gastroenterology Institute
🇺🇸
Suffolk, Virginia, United States
Wisconsin Center for Advanced Research
🇺🇸
Milwaukee, Wisconsin, United States
Mayo Clinic Rochester
🇺🇸
Rochester, Minnesota, United States
Yale University Section of Digestive Diseases and Liver Diseases
🇺🇸
New Haven, Connecticut, United States
Austin Regional Clinic
🇺🇸
Austin, Texas, United States