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

NCT ID: NCT03728348

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 983 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-06
• Study Completion Date: 2019-06-18

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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subject aged 45-49 with Average CRC Risk

Subject aged 45-49 with average risk for development of CRC.

mt-sDNA screening test

Intervention Type: DIAGNOSTIC_TEST

Stool samples will be collected by the subject for the mt-sDNA screening test.

Colonoscopy

Intervention Type: PROCEDURE

Subjects will undergo a screening colonoscopy.

Interventions

mt-sDNA screening test

Stool samples will be collected by the subject for the mt-sDNA screening test.

Intervention Type: DIAGNOSTIC_TEST

Colonoscopy

Subjects will undergo a screening colonoscopy.

Intervention Type: PROCEDURE

Other Intervention Names

Cologuard

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Exact Sciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Imperiale, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Mayo Clinic Arizona

Phoenix, Arizona, United States

Ventura County Gastroenterology

Camarillo, California, United States

Alliance Research Centers

Laguna Hills, California, United States

Focilmed

Oxnard, California, United States

Desert Oasis Healthcare Medical Group

Palm Springs, California, United States

Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, United States

Yale University Section of Digestive Diseases and Liver Diseases

New Haven, Connecticut, United States

Precision Clinical Research, LLC

Lauderdale Lakes, Florida, United States

Northshore University Health System Evanston Hospital

Evanston, Illinois, United States

DM Clinical Research- Southwest Gastroenterology

Oak Lawn, Illinois, United States

Deaconess Clinic- Mt. Pleasant

Evansville, Indiana, United States

Indiana University, Eskanazi Hospital

Indianapolis, Indiana, United States

Deaconess Clinic- Gateway

Newburgh, Indiana, United States

Johnson County ClinTrials, LLC

Lenexa, Kansas, United States

New Orleans Research Institute

Metairie, Louisiana, United States

Delta Research Partners, LLC

Monroe, Louisiana, United States

Louisiana Research Center

Shreveport, Louisiana, United States

Investigative Clinical Research

Annapolis, Maryland, United States

Centennial Medical Group

Elkridge, Maryland, United States

Capitol Research

Rockville, Maryland, United States

Commonwealth Clinical Studies

Brockton, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

United Medical Associates

Binghamton, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Asheville Gastroenterology Associates

Asheville, North Carolina, United States

Charlotte Gastroenterology & Hepatology, PLLC

Charlotte, North Carolina, United States

Wilmington Gastroenterology Associates

Wilmington, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Family Practice Center of Wooster, Inc./Clinical Trial Developers

Massillon, Ohio, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Comprehensive Internal Medicine, Inc.

Wooster, Ohio, United States

Gastroenterology Associates, PA

Greenville, South Carolina, United States

Gastro One

Germantown, Tennessee, United States

Quality Medical Research, PLLC

Nashville, Tennessee, United States

Austin Regional Clinic

Austin, Texas, United States

University of Texas Health Science Center- McGovern Medical School

Houston, Texas, United States

DM Clinical Research- PCP for Life

Houston, Texas, United States

Virginia Gastroenterology Institute

Suffolk, Virginia, United States

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33436397 (View on PubMed)

Provided Documents

Document Type: Study Protocol: Version 2

View Document

Document Type: Study Protocol: Version 1

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-10

Identifier Type: -

Identifier Source: org_study_id