Scripps Genomics Health Initiative

NCT ID: NCT00808587

Last Updated: 2025-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Genes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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No Treatment

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Navigenics, Inc.

INDUSTRY

Sponsor Role collaborator

Affymetrix, Inc.

INDUSTRY

Sponsor Role collaborator

Scripps Translational Science Institute

OTHER

Sponsor Role lead

Responsible Party

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Eric Topol, MD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric J. Topol, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Translational Science Institute

Locations

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Scripps Health

San Diego, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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HSC# 08-5069

Identifier Type: -

Identifier Source: org_study_id

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