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Trial record 1 of 1 for:    NCT00808587
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Scripps Genomics Health Initiative

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: NCT00808587
Recruitment Status : Active, not recruiting
First Posted : December 16, 2008
Last Update Posted : March 17, 2021
Navigenics, Inc.
Affymetrix, Inc.
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute

Brief Summary:

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 or disease

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Scripps Genomics Health Initiative
Study Start Date : October 2008
Actual Primary Completion Date : September 2009
Estimated Study Completion Date : March 2029

Resource links provided by the National Library of Medicine

No Treatment

Primary Outcome Measures :
  1. The primary endpoint will be lifestyle changes based on the subject's genetic risk(s). [ Time Frame: Three and 12 months ]

Secondary Outcome Measures :
  1. 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 ]

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Scripps Health employees, friends, family, and the general population

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.

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): NCT00808587

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United States, California
Scripps Health
San Diego, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Navigenics, Inc.
Affymetrix, Inc.
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Principal Investigator: Eric J. Topol, MD Scripps Translational Science Institute
Additional Information:
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Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT00808587    
Other Study ID Numbers: HSC# 08-5069
First Posted: December 16, 2008    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Keywords provided by Eric Topol, MD, Scripps Translational Science Institute:
Genomic Scan
Personalized Medicine
Gene testing