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Scripps Genomics Health Initiative

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Navigenics, Inc.
Affymetrix, Inc.
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00808587
First received: December 9, 2008
Last updated: January 20, 2012
Last verified: January 2012
History of Changes
  Purpose

The specific aims for this project are to enroll up to 10,000 subjects who will have their genomes surveyed using the Navigenics™ Health Compass technology. The Navigenics Health Compass helps you understand what your genetic variants have to say about the future of your health, and gives you action steps to take control of your health today. In addition, the investigators will assess how the Navigenics Health Compass, results affect lifestyle decisions. The phenotyping information that can be analyzed with the resulting Navigenics genotype information will assist in identifying genetic variations associated with other traits and diseases.

The uses of molecular markers such as cholesterol and glucose levels to assess disease risk are well established in clinical medicine today. Although these tools are useful in screening for subclinical disease, their predictive value is limited. Until recently, these molecular markers were the best risk assessment and screening tools in existence. Since the completion of the Human Genome Project, the era of personalized medicine, which exploits knowledge of the genes an individual carries that may predispose him/her to disease, has come to the forefront of research.

The Navigenics Health Compass technology assesses risk for about over 20 common diseases and provides subjects with more accurate assessments of their individual predictive risk for developing these conditions than traditional biomarkers such as cholesterol and glucose levels. This may positively influence changes in lifestyle, as well as decisions to seek further medical evaluation associated with preventive strategies.


Condition
Genes

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Scripps Genomics Health Initiative

Further study details as provided by Scripps Translational Science Institute:

Primary Outcome Measures:
  • The primary endpoint will be lifestyle changes based on the subject's genetic risk(s). [ Time Frame: Three and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary endpoint will be to evaluate the frequency of subjects changing their lifestyle based on factors such as education, gender, disease history, and related items. [ Time Frame: Three and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: October 2008
Estimated Study Completion Date: March 2029
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
No Treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Scripps Health employees, friends, family, and the general population

Criteria

Inclusion Criteria:

  • Age 18 or older
  • Able to read, write, and fluently understand English.
  • Be reliable, cooperative, and willing to comply with all protocol specified procedures.
  • Be able to understand and grant informed consent.
  • Be able to provide payment for services rendered.
  • Have an email address.

Exclusion Criteria:

  • Intake of anything orally, i.e., food, beverage, cigarettes, brushing of teeth, 30 minutes prior to providing saliva sample.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808587

Locations
United States, California
Scripps Health
San Diego, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Navigenics, Inc.
Affymetrix, Inc.
Investigators
Principal Investigator: Eric J. Topol, MD Scripps Translational Science Institute
  More Information

Additional Information:
Enrollment website  This link exits the ClinicalTrials.gov site
Navigenics Member Services: 866-522-1585  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT00808587     History of Changes
Other Study ID Numbers: HSC# 08-5069
Study First Received: December 9, 2008
Last Updated: January 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Translational Science Institute:
Genomic Scan
Personalized Medicine
Gene testing

ClinicalTrials.gov processed this record on June 17, 2013