We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00187668
Recruitment Status : Unknown
Verified October 2014 by University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Collect DNA from well-characterized healthy volunteers.

Condition or disease
Focus Groups

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
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)
Study Start Date : February 2004
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

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.



Primary Outcome Measures :
  1. Healthy Control [ Time Frame: On-going ]
    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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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 specified ethnic groups
  • Subjects must be between 18-40 years of age

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187668     History of Changes
Other Study ID Numbers: 701
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014

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