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MyGeneRank: A Digital Platform for Next-Generation Genetic Studies

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03277365
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Ali Torkamani, Scripps Translational Science Institute

Brief Summary:

Many conditions affecting health are caused by a combination of environment, behaviors, and genes. While individuals can alter some factors in their lives to reduce the chances of developing different diseases (e.g., not smoking cigarettes), the contribution from genetic risk encoded by DNA remains with people throughout their lives. Scientists are still trying to determine the entirety of genetic factors that influence disease, but for some conditions it has been shown that the factors identified thus far can begin to identify people at high to low genetic risk. Looking across the genome, scientists can calculate a cumulative genetic risk score - which can be used to rank genetic risk compared to other worldwide populations.

The goal of this study is to determine how genetic risk influences health decisions and other things that can be controlled in life. The first genetic risk score is calculated for coronary heart disease (CAD). CAD ultimately leads to heart attacks, heart failure and sometimes sudden cardiac death and is the main reason heart disease remains as the number one cause of death worldwide. Other researchers have shown that this genetic risk score can be used to identify people with low, intermediate, and high risk for coronary heart disease. It has also been shown that the use of statins (cholesterol lowering drugs) provides greater benefit and protection against heart attack for people with high genetic risk for coronary artery disease.

Leveraging the Apple ResearchKit and the ResearchKit linked 23andMe API, customers of 23andMe are able to provide researchers access to their genomic data. Participants will use the ResearchKit app to provide consent, view study information, answer surveys, and contact the study team.

Participants will be asked to complete 3 surveys. One before viewing genetic risk scores, one immediately after viewing scores, and one 6 months after viewing scores.


Condition or disease Intervention/treatment Phase
Heart Diseases Other: Receive genetic risk information Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: MyGeneRank: A Digital Platform for Next-Generation Genetic Studies
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : September 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases


Intervention Details:
  • Other: Receive genetic risk information
    Risk scores are provided by ResearchKit app.


Primary Outcome Measures :
  1. Initiation of Statin Therapy [ Time Frame: 6 months ]
    Participant begins taking Statin as indicated by survey.



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
Criteria

Inclusion Criteria:

  • Customer of 23andMe willing to share their 23andMe data
  • User of Apple mobile device

Exclusion Criteria:

  • Under 18 years old

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): NCT03277365


Contacts
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Contact: Jennifer Wagner, RN 858-784-2028 generank@scripps.edu

Locations
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United States, California
Scripps Translational Science Institute Recruiting
La Jolla, California, United States, 92037
Contact: Emily Spencer, PhD       generank@scripps.edu   
Sponsors and Collaborators
Scripps Translational Science Institute
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Responsible Party: Ali Torkamani, Director, Genomics, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT03277365    
Other Study ID Numbers: 16-6835
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases