GenesNCT00808587
Scripps Genomics Health Initiative
An observational study of Genes, run by Scripps Translational Science Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genes
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Scripps Health employees, friends, family, and the general population
Who may be able to join
- 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.
Who cannot join
- Intake of anything orally, i.e., food, beverage, cigarettes, brushing of teeth, 30 minutes prior to providing saliva sample.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Genes
- Keywords
- Genomic Scan, Personalized Medicine, Gene testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No Treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be lifestyle changes based on the subject's genetic risk(s).
Measured: Three and 12 months
Secondary outcomes (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.
Measured: Three and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2009
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GenesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Navigenics, Inc., Affymetrix, Inc.
- Responsible party
- Principal investigator, Eric Topol, MD, Scripps Translational Science Institute
- Investigators
- Eric J. Topol, MD, Principal investigator, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808587
- Sponsor's protocol ID
- HSC# 08-5069
- Status last verified
- Jan 2025
- First submitted
- 9 Dec 2008
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scripps Genomics Health Initiative
- ClinicalTrials.gov ID
- NCT00808587
- Acronym / sponsor ID
- HSC# 08-5069
- Conditions
- Genes
- Keywords
- Genomic Scan, Personalized Medicine, Gene testing
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Collaborators
- Navigenics, Inc., Affymetrix, Inc.
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2029 (estimated)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Scripps Health employees, friends, family, and the general population
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Intake of anything orally, i.e., food, beverage, cigarettes, brushing of teeth, 30 minutes prior to providing saliva sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint will be lifestyle changes based on the subject's genetic risk(s).
Time frame: Three and 12 months
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Scripps Genomic Health InitiativeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J. Topol, MD principal investigator
Scripps Translational Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genes, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be lifestyle changes based on the subject's genetic risk(s). (time frame: Three and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.