Trials / Completed
CompletedNCT03640234
Return of Actionable Variants Empirical Study
Return of Actionable Variants Empirical (RAVE) Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 418 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
This is a genomic implementation project with ancillary studies to understand the impact on patients' health and well-being of returning genomic results to them and depositing those results in the medical record.
Detailed description
Study participant DNA samples will be sequenced for 109 genes of interest along with genotyping of select polymorphisms. Genetic tests will be performed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab (Baylor Human Genome Sequencing Laboratory). Selected results (pathogenic/likely pathogenic) will be returned to participants by a genetic counselor and deposited into the Electronic Health Record (EHR).
Conditions
Timeline
- Start date
- 2016-02-25
- Primary completion
- 2022-09-01
- Completion
- 2022-09-01
- First posted
- 2018-08-21
- Last updated
- 2022-09-27
Source: ClinicalTrials.gov record NCT03640234. Inclusion in this directory is not an endorsement.