Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-03-05 @ 11:18 PM
Study NCT ID:
NCT03640234
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2018-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Return of Actionable Variants Empirical Study
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Return of Actionable Variants Empirical (RAVE) Study
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAVE
Brief 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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01HG006379 | NIH | None | https://reporter.nih.gov/quic… | View |