Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-29 @ 8:46 AM
Study NCT ID:
NCT00187668
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)
Status:
COMPLETED
Status Verified Date:
2023-08
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:
SOPHIE
Brief Summary:
Collect DNA from well-characterized healthy volunteers.
Detailed Description:
DNA and plasma will be used to identify and determine allele frequencies of genetic variants in membrane transporters and other genes relevant to human disease or drug response, including drug metabolizing enzymes, collagen, race/ethnicity, neurovascular disease, asthma/allergy/lung disease, and cardiovascular disease. This phase of the study will serve as the hypothesis-generating phase for future studies by identifying genetic variants and determining allele frequencies among an ethnically diverse cohort of healthy volunteers. Future investigations (separate IRB applications) will attempt to correlate genotypes to phenotypes among this cohort of volunteers. The allele identification and frequency data from this group of healthy volunteers will also be used to design association studies in relevant disease populations.
Determine if identified sequence variants are associated with gain or loss of in vitro biologic function using lymphocytes obtained from patients.
Determine if identified sequence variants are associated with gain or loss of in vitro biologic function using lymphocytes obtained from patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: