Trials / Completed
CompletedNCT04144738
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 26,758 (actual)
- Sponsor
- Exact Sciences Corporation · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-11-15
- Primary completion
- 2023-03-30
- Completion
- 2023-03-30
- First posted
- 2019-10-30
- Last updated
- 2023-09-01
Locations
195 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04144738. Inclusion in this directory is not an endorsement.