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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144738
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Study Description
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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.

Condition or disease Intervention/treatment
Colorectal Cancer Diagnostic Test: mt-sDNA 2.0 screening test Diagnostic Test: FIT test Procedure: Colonoscopy

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 Design
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Study Type : Observational
Estimated Enrollment : 24000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Individuals eligible for CRC Screening
Individuals who are 40 years of age and older, eligible for CRC screening, and scheduled for a screening colonoscopy.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity for CRC with the mt-sDNA 2.0 test [ Time Frame: Through study completion, an average of 180 days ]
  2. Specificity with the mt-sDNA 2.0 test [ Time Frame: Through study completion, an average of 180 days ]

Secondary Outcome Measures :
  1. Sensitivity for advanced precancerous lesions [ Time Frame: Through study completion, an average of 180 days ]
  2. Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT) [ Time Frame: Through study completion, an average of 180 days ]
  3. Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT). [ Time Frame: Through study completion, an average of 180 days ]
  4. Specificity for no colorectal neoplastic findings [ Time Frame: Through study completion, an average of 180 days ]

Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144738


Contacts
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Contact: Marla Kuleszynski 608-400-3569 mkuleszynski@exactsciences.com
Contact: Dania Brooks 608-293-3437 dbrooks@exactsciences.com

Locations
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Sponsors and Collaborators
Exact Sciences Corporation
Investigators
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Principal Investigator: Thomas Imperiale, MD Indiana University
More Information
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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT04144738    
Other Study ID Numbers: 2019-01
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: January 2022
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Exact Sciences Corporation:
Sample Collection
Stool DNA
Colonoscopy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases