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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728348
• Other study ID #: 2018-10
• Status: Completed
• Start date: November 6, 2018
• Est. completion date: June 18, 2019

Study information

• Verified date: June 2021
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 983
• Est. completion date: June 18, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Procedure:
• Colonoscopy
Subjects will undergo a screening colonoscopy.

Locations

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

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	Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49	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)	Through study completion, an average of 60 days