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Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)

Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00187668
Acronym
SOPHIE
Enrollment
500
Registered
2005-09-16
Start date
2004-02-29
Completion date
2023-08-31
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focus Groups

Keywords

Healthy Cohort

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.

Interventions

None listed

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy adult subjects of both genders and specified ethnic groups * Subjects must be between 18-40 years of age

Exclusion criteria

* Smokers * Drink \> 2 alcoholic beverages/day * Take any chronic medication

Design outcomes

Primary

MeasureTime frameDescription
Healthy ControlOn-goingAmass a cohort of healthy controls to be used for future genotype to phenotype studies.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026