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Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 20, 2014
Last verified: October 2014

September 13, 2005
October 20, 2014
February 2004
December 2014   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00187668 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)
Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)

Collect DNA from well-characterized healthy volunteers.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

40 mL of blood for DNA extraction

Non-Probability Sample

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

Focus Groups
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
United States
 
NCT00187668
701
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Kathleen M Giacomini, PhD University of California, San Francisco
University of California, San Francisco
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP