Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728348
Recruitment Status : Completed
First Posted : November 2, 2018
Results First Posted : June 4, 2021
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Tracking Information
First Submitted Date October 31, 2018
First Posted Date November 2, 2018
Results First Submitted Date January 20, 2021
Results First Posted Date June 4, 2021
Last Update Posted Date June 4, 2021
Actual Study Start Date November 6, 2018
Actual Primary Completion Date June 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2021)
Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49 [ Time Frame: 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)
Original Primary Outcome Measures
 (submitted: October 31, 2018)
Specificity of mt-sDNA Test [ Time Frame: Study Duration: Duration of study participation for each subject will be approximately 60 days from enrollment into the study. ]
The primary objective is to confirm the specificity of the mt-sDNA test (Cologuard) in an average risk population, ages 45-49.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition Colorectal Cancer
Intervention
  • Diagnostic Test: mt-sDNA screening test
    Stool samples will be collected by the subject for the mt-sDNA screening test.
    Other Name: Cologuard
  • Procedure: Colonoscopy
    Subjects will undergo a screening colonoscopy.
Study Groups/Cohorts Subject aged 45-49 with Average CRC Risk
Subject aged 45-49 with average risk for development of CRC.
Interventions:
  • Diagnostic Test: mt-sDNA screening test
  • Procedure: Colonoscopy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 12, 2019)
983
Original Estimated Enrollment
 (submitted: October 31, 2018)
942
Actual Study Completion Date June 18, 2019
Actual Primary Completion Date June 18, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 49 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03728348
Other Study ID Numbers 2018-10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (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.
Responsible Party Exact Sciences Corporation
Study Sponsor Exact Sciences Corporation
Collaborators Not Provided
Investigators
Principal Investigator: Thomas Imperiale, MD Indiana University
PRS Account Exact Sciences Corporation
Verification Date June 2021