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RecruitingNCT03277365Updated Apr 17, 2024

MyGeneRank: A Digital Platform for Next-Generation Genetic Studies

An interventional study of Receive genetic risk information in Heart Diseases, sponsored by Scripps Translational Science Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by Scripps Translational Science Institute · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Diseases

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Under 18 years old
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100,000 participants (estimated)

Interventions

  • OtherReceive genetic risk information

    Risk scores are provided by ResearchKit app.

05

What researchers measure

Primary outcomes

  1. Initiation of Statin Therapy

    Participant begins taking Statin as indicated by survey.

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Scripps Translational Science Institute
    La Jolla, California 92037, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03277365
Lead sponsor
Scripps Translational Science Institute
Responsible party
Ali Torkamani (Director, Genomics, Scripps Translational Science Institute) — Principal investigator
First posted
Sep 11, 2017
Start date
Sep 26, 2017
Primary completion
Feb 11, 2026 (estimated)
Completion
Sep 2030 (estimated)
Last update
Apr 17, 2024

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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