Clinical trial NCT03728348: 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
Official title: 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
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: 2018-11-02
Enrollment: 983
Sex: ALL
Minimum age (years): 45
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 45-49 years of age who are at average risk for development of CRC. 942 subjects are targeted to enroll.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Exclusion Criteria:

1. Subject has a history of CRC or adenoma.
2. Subject has ≥2 first-degree relatives who have been diagnosed with CRC
3. Subject has one first-degree relative with CRC diagnosed before the age of 60.
4. 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.
5. 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.
6. 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").
7. Subjects with Cronkhite-Canada Syndrome.
8. Subject has a diagnosis of inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
9. Subject has a history of aerodigestive tract cancer.
10. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
11. Subject has any condition that in the opinion of the investigator should preclude participation in the study.

Primary outcomes:
measure: Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49
timeFrame: Through study completion, an average of 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Camarillo
country: United States
facility: Ventura County Gastroenterology
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Oxnard
country: United States
facility: Focilmed
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare Medical Group
state: California
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County
state: Connecticut
city: New Haven
country: United States
facility: Yale University Section of Digestive Diseases and Liver Diseases
state: Connecticut
city: Lauderdale Lakes
country: United States
facility: Precision Clinical Research, LLC
state: Florida
city: Evanston
country: United States
facility: Northshore University Health System Evanston Hospital
state: Illinois
city: Oak Lawn
country: United States
facility: DM Clinical Research- Southwest Gastroenterology
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic- Mt. Pleasant
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University, Eskanazi Hospital
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Clinic- Gateway
state: Indiana
city: Lenexa
country: United States
facility: Johnson County ClinTrials, LLC
state: Kansas
city: Metairie
country: United States
facility: New Orleans Research Institute
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center
state: Louisiana
city: Annapolis
country: United States
facility: Investigative Clinical Research
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Rockville
country: United States
facility: Capitol Research
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology, PLLC
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Gastroenterology Associates
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Massillon
country: United States
facility: Family Practice Center of Wooster, Inc./Clinical Trial Developers
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Wooster
country: United States
facility: Comprehensive Internal Medicine, Inc.
state: Ohio
city: Greenville
country: United States
facility: Gastroenterology Associates, PA
state: South Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research, PLLC
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center- McGovern Medical School
state: Texas
city: Houston
country: United States
facility: DM Clinical Research- PCP for Life
state: Texas
city: Suffolk
country: United States
facility: Virginia Gastroenterology Institute
state: Virginia
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:
citation: Imperiale TF, Kisiel JB, Itzkowitz SH, Scheu B, Duimstra EK, Statz S, Berger BM, Limburg PJ. Specificity of the Multi-Target Stool DNA Test for Colorectal Cancer Screening in Average-Risk 45-49 Year-Olds: A Cross-Sectional Study. Cancer Prev Res (Phila). 2021 Apr;14(4):489-496. doi: 10.1158/1940-6207.CAPR-20-0294. Epub 2021 Jan 12.