Overview

This trial is active, not recruiting.

Condition genes
Sponsor Scripps Translational Science Institute
Collaborator Navigenics, Inc.
Start date October 2008
End date September 2009
Trial size 10000 participants
Trial identifier NCT00808587, HSC# 08-5069

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm

Primary Outcomes

Measure
The primary endpoint will be lifestyle changes based on the subject's genetic risk(s).
time frame: Three and 12 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Scripps Genomics Health Initiative
Principal investigator Eric J. Topol, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Scripps Translational Science Institute.