MyGeneRank: A Digital Platform for Next-Generation Genetic Studies

Sponsor
Scripps Translational Science Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03277365
Collaborator
(none)
100,000
1
155.2
644.5

Study Details

Study Description

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
  • Other: Receive genetic risk information
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 26, 2017
Anticipated Primary Completion Date :
Sep 1, 2027
Anticipated Study Completion Date :
Sep 1, 2030

Outcome Measures

Primary Outcome Measures

  1. Initiation of Statin Therapy [6 months]

    Participant begins taking Statin as indicated by survey.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Customer of 23andMe willing to share their 23andMe data

  • User of Apple mobile device

Exclusion Criteria:
  • Under 18 years old

Contacts and Locations

Locations

Site City State Country Postal Code
1 Scripps Translational Science Institute La Jolla California United States 92037

Sponsors and Collaborators

  • Scripps Translational Science Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ali Torkamani, Director, Genomics, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT03277365
Other Study ID Numbers:
  • 16-6835
First Posted:
Sep 11, 2017
Last Update Posted:
Mar 18, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2021