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
1 other identifier
observational
983
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Shorter than P25 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2018
CompletedFirst Posted
Study publicly available on registry
November 2, 2018
CompletedStudy Start
First participant enrolled
November 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2019
CompletedResults Posted
Study results publicly available
June 4, 2021
CompletedJune 4, 2021
June 1, 2021
7 months
October 31, 2018
January 20, 2021
June 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Subject aged 45-49 with Average CRC Risk
Subject aged 45-49 with average risk for development of CRC.
Interventions
Stool samples will be collected by the subject for the mt-sDNA screening test.
Subjects will undergo a screening colonoscopy.
Eligibility Criteria
Subjects 45-49 years of age who are at average risk for development of CRC. 942 subjects are targeted to enroll.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Ventura County Gastroenterology
Camarillo, California, 93012, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
Focilmed
Oxnard, California, 93030, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606, United States
Yale University Section of Digestive Diseases and Liver Diseases
New Haven, Connecticut, 06520, United States
Precision Clinical Research, LLC
Lauderdale Lakes, Florida, 33319, United States
Northshore University Health System Evanston Hospital
Evanston, Illinois, 60201, United States
DM Clinical Research- Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
Deaconess Clinic- Mt. Pleasant
Evansville, Indiana, 47725, United States
Indiana University, Eskanazi Hospital
Indianapolis, Indiana, 46202, United States
Deaconess Clinic- Gateway
Newburgh, Indiana, 47630, United States
Johnson County ClinTrials, LLC
Lenexa, Kansas, 66219, United States
New Orleans Research Institute
Metairie, Louisiana, 70006, United States
Delta Research Partners, LLC
Monroe, Louisiana, 71201, United States
Louisiana Research Center
Shreveport, Louisiana, 71103, United States
Investigative Clinical Research
Annapolis, Maryland, 21401, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
Capitol Research
Rockville, Maryland, 20850, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
United Medical Associates
Binghamton, New York, 13901, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 28207, United States
Wilmington Gastroenterology Associates
Wilmington, North Carolina, 28403, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Family Practice Center of Wooster, Inc./Clinical Trial Developers
Massillon, Ohio, 44647, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Comprehensive Internal Medicine, Inc.
Wooster, Ohio, 44691, United States
Gastroenterology Associates, PA
Greenville, South Carolina, 29615, United States
Gastro One
Germantown, Tennessee, 38138, United States
Quality Medical Research, PLLC
Nashville, Tennessee, 37211, United States
Austin Regional Clinic
Austin, Texas, 78726, United States
University of Texas Health Science Center- McGovern Medical School
Houston, Texas, 77030, United States
DM Clinical Research- PCP for Life
Houston, Texas, 77070, United States
Virginia Gastroenterology Institute
Suffolk, Virginia, 23434, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
Related Publications (1)
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.
PMID: 33436397DERIVED
Biospecimen
Residual stool samples may be used to develop and evaluate the performance of biomarker assays to detect cancers. Sample may be stored for up to 20 years. These stool samples will be de-identified.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Subjects with colonoscopic non-advanced adenoma findings were included in the specificity analysis as disease status negative. The colonoscopically 'negative' population included subjects with no findings on colonoscopy and have a higher specificity.
Results Point of Contact
- Title
- Alexandra Massoud, Sr. Director of Clinical Affairs
- Organization
- Exact Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Imperiale, MD
Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2018
First Posted
November 2, 2018
Study Start
November 6, 2018
Primary Completion
June 18, 2019
Study Completion
June 18, 2019
Last Updated
June 4, 2021
Results First Posted
June 4, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be available from 2 years and ending 4 years after publication.
- Access Criteria
- Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research.
Individual participant data that underlie the results reported in publications of the study will be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be shared. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.