Scripps Genomics Health Initiative

Genes Clinical Trial

Official title:

Scripps Genomics Health Initiative

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00808587
• Other study ID #: HSC# 08-5069
• Status: Active, not recruiting
• Start date: October 2008
• Est. completion date: March 2029

Study information

• Verified date: March 2021
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: March 2029
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genes

Locations

Country	Name	City	State
United States	Scripps Health	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	Affymetrix, Inc., Navigenics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be lifestyle changes based on the subject's genetic risk(s).		Three and 12 months
Secondary	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.		Three and 12 months

External Links

•   Scripps Genomic Health Initiative