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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04144738|
Recruitment Status : Active, not recruiting
First Posted : October 30, 2019
Last Update Posted : February 27, 2023
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|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Diagnostic Test: mt-sDNA 2.0 screening test Diagnostic Test: FIT test Procedure: Colonoscopy|
|Study Type :||Observational|
|Estimated Enrollment :||29000 participants|
|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 :||March 31, 2023|
|Estimated Study Completion Date :||March 31, 2023|
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.
Subjects will undergo a screening colonoscopy.
- 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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
Subjects must meet the following criteria to be eligible for the study:
- Subject is ≥ 40 years of age at the time of enrollment.
- Subject presents for a screening colonoscopy per standard of care.
- Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
- Subject is able and willing to sign informed consent
- Subject has a history of CRC or advanced precancerous lesions.
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.
- Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
- Subject has a diagnosis of Cronkhite-Canada Syndrome.
- Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
- 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.
- Subject has had overt rectal bleeding within the previous 30 days.
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
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
|Principal Investigator:||Thomas Imperiale, MD||Indiana University|
|Responsible Party:||Exact Sciences Corporation|
|Other Study ID Numbers:||
|First Posted:||October 30, 2019 Key Record Dates|
|Last Update Posted:||February 27, 2023|
|Last Verified:||February 2023|
|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.|
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 email@example.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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases