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Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

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ClinicalTrials.gov Identifier: NCT04144738
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Tracking Information
First Submitted Date October 28, 2019
First Posted Date October 30, 2019
Last Update Posted Date November 30, 2021
Actual Study Start Date November 15, 2019
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2020)
  • Sensitivity for CRC with the mt-sDNA 2.0 test [ Time Frame: Through study completion, an average of 180 days ]
  • Specificity with the mt-sDNA 2.0 test [ Time Frame: Through study completion, an average of 180 days ]
Original Primary Outcome Measures
 (submitted: October 28, 2019)
  • Sensitivity for CRC with the mt-sDNA 2.0 test [ Time Frame: Through study completion, an average of 180 days ]
    To test if the mt-sDNA 2.0 test sensitivity rejects the 75% null hypothesis versus a higher 90% alternative hypothesis
  • Specificity with the mt-sDNA 2.0 test [ Time Frame: Through study completion, an average of 180 days ]
    To test if the mt-sDNA 2.0 test specificity rejects the 86.6% null hypothesis versus a higher 88% alternative hypothesis
Change History
Current Secondary Outcome Measures
 (submitted: December 29, 2020)
  • Sensitivity for advanced precancerous lesions [ Time Frame: Through study completion, an average of 180 days ]
  • Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT) [ Time Frame: Through study completion, an average of 180 days ]
  • Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT). [ Time Frame: Through study completion, an average of 180 days ]
  • Specificity for no colorectal neoplastic findings [ Time Frame: Through study completion, an average of 180 days ]
Original Secondary Outcome Measures
 (submitted: October 28, 2019)
  • Sensitivity for advanced adenoma [ Time Frame: Through study completion, an average of 180 days ]
    To test if the mt-sDNA 2.0 test sensitivity for subjects with advanced adenoma findings rejects a 42.4% null hypothesis versus a higher 48% alternative hypothesis.
  • Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT) [ Time Frame: Through study completion, an average of 180 days ]
    To compare the mt-sDNA 2.0 test sensitivity for CRC detection to a commercially available fecal immunochemical test (FIT).
  • Sensitivity for advanced adenoma compared to commercially available fecal immunochemical test (FIT). [ Time Frame: Through study completion, an average of 180 days ]
    To compare the mt-sDNA 2.0 test sensitivity for advanced adenoma detection to a commercially available fecal immunochemical test (FIT).
  • Specificity for no colorectal neoplastic findings [ Time Frame: Through study completion, an average of 180 days ]
    To test if the mt-sDNA 2.0 test specificity for subjects with no colorectal neoplastic findings rejects an 88.4% null hypothesis versus a higher 90% alternative hypothesis.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
Official Title Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
Brief Summary The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.
Detailed Description Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subject will complete the mt-sDNA 2.0 test and the commercially available FIT, followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test and FIT will not be provided to investigators for clinical management of the study subject. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathologial review of reports or tissue (if applicable) will remain blinded to the results of the mt-sDNA 2.0 screening test results.
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 will be used to develop and evaluate the performance of biomarker assays to detect cancers and advanced precancerous lesions. Samples may be stored for up to 20 years. These stool samples will be de-identified.
Sampling Method Non-Probability Sample
Study Population Subjects 40 years of age and older who are eligible for CRC screening and scheduled for a screening colonoscopy. 24,000 subjects are targeted to enroll.
Condition Colorectal Cancer
Intervention
  • Diagnostic Test: mt-sDNA 2.0 screening test
    Stool samples will be collected by the subject for the mt-sDNA screening test.
  • Diagnostic Test: FIT test
    Stool samples will be collected by the subject for the FIT test.
  • Procedure: Colonoscopy
    Subjects will undergo a screening colonoscopy.
Study Groups/Cohorts Individuals eligible for CRC Screening
Individuals who are 40 years of age and older, eligible for CRC screening, and scheduled for a screening colonoscopy.
Interventions:
  • Diagnostic Test: mt-sDNA 2.0 screening test
  • Diagnostic Test: FIT test
  • Procedure: Colonoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 8, 2021)
24000
Original Estimated Enrollment
 (submitted: October 28, 2019)
12500
Estimated Study Completion Date October 31, 2022
Estimated Primary Completion Date October 31, 2022   (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 ≥ 40 years of age at the time of enrollment.
  2. Subject presents for a screening colonoscopy per standard of care.
  3. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
  4. Subject is able and willing to sign informed consent

Exclusion Criteria:

  1. Subject has a history of CRC or advanced precancerous lesions.
  2. Subject has a diagnosis or medical / family 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, or Familial Hyperplastic Polyposis.
  3. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
  4. Subject has a diagnosis of Cronkhite-Canada Syndrome.
  5. Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
  6. Subject has undergone a colonoscopy within the previous 9 years with the exception of a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
  7. Subject has had overt rectal bleeding within the previous 30 days.
  8. 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 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Alisa Hewitt 608-405-2197 ahewitt@exactsciences.com
Contact: Dania Brooks 608-293-3437 dbrooks@exactsciences.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04144738
Other Study ID Numbers 2019-01
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: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in publications of the study may be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, and informed consent form may also be shared. Data may 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)
Time Frame: Data may 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 November 2021