Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187668
First received: September 13, 2005
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

Collect DNA from well-characterized healthy volunteers.


Condition
Focus Groups

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Healthy Control [ Time Frame: On-going ] [ Designated as safety issue: No ]
    Amass a cohort of healthy controls to be used for future genotype to phenotype studies.


Biospecimen Retention:   Samples With DNA

40 mL of blood for DNA extraction


Estimated Enrollment: 500
Study Start Date: February 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Smokers
  • Drink > 2 alcoholic beverages/day
  • Take any chronic medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187668

Locations
United States, California
San Francisco General Hopsital CTSI CRC Recruiting
San Francisco, California, United States, 94143
Contact: Hector Vizoso, RN-BC, MSN    415-206-3317    hvizoso@sfghgcrc.ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathleen M Giacomini, PhD University of California, San Francisco
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187668     History of Changes
Other Study ID Numbers: 701
Study First Received: September 13, 2005
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Healthy Cohort

ClinicalTrials.gov processed this record on July 22, 2014