At a glance
ClinicalIndex Comparison RecordN/ACompleted· 26,758 enrolled
Drug / intervention
mt-sDNA 2.0 screening test +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
In Brief
An observational study evaluating mt-sDNA 2.0 screening test, FIT test, and 1 other intervention for Colorectal Cancer. Completed, enrolled 26,758 participants across 195 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartNov 2019
Primary CompletionMar 2023
TodayJul 2026
First PostedOct 30, 2019
Enrollment StartNov 15, 2019
Primary CompletionMar 30, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.7 years ago
Interventions
mt-sDNA 2.0 screening testother
Stool samples will be collected by the subject for the mt-sDNA screening test.
FIT testother
Stool samples will be collected by the subject for the FIT test.
Colonoscopyprocedure
Subjects will undergo a screening colonoscopy.