Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study) (SOPHIE)

August 10, 2023 updated by: University of California, San Francisco
Collect DNA from well-characterized healthy volunteers.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • San Francisco General Hopsital CTSI CRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy participants that are willing to be called back for subsequent genotype to phenotype studies.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
African American
Must self identify as African American with parents and grandparents of the same ethnicity. Must be healthy taking no over the counter medications or prescription medications.
Cuacasian
Must self identify as Caucasian with parents and grandparents of the same ethnicity. Must be healthy taking no over the counter medications or prescription medications.
Hispanic
Must self identify as Hispanic with parents and grandparents of the same ethnicity. Must be healthy taking no over the counter medications or prescription medications.
Asian
Must self identify as Asian with parents and grandparents of the same ethnicity. Must be healthy taking no over the counter medications or prescription medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthy Control
Time Frame: On-going
Amass a cohort of healthy controls to be used for future genotype to phenotype studies.
On-going

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Kathleen M Giacomini, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 701 (Registry Identifier: RSO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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