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MyGeneRank: A Digital Platform for Next-Generation Genetic Studies

Primary Purpose

Heart Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Receive genetic risk information
Sponsored by
Scripps Translational Science Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18 years old

Sites / Locations

  • Scripps Translational Science InstituteRecruiting

Outcomes

Primary Outcome Measures

Initiation of Statin Therapy
Participant begins taking Statin as indicated by survey.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2017
Last Updated
November 3, 2022
Sponsor
Scripps Translational Science Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03277365
Brief Title
MyGeneRank: A Digital Platform for Next-Generation Genetic Studies
Official Title
MyGeneRank: A Digital Platform for Next-Generation Genetic Studies
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2017 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
September 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Translational Science Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Receive genetic risk information
Intervention Description
Risk scores are provided by ResearchKit app.
Primary Outcome Measure Information:
Title
Initiation of Statin Therapy
Description
Participant begins taking Statin as indicated by survey.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Customer of 23andMe willing to share their 23andMe data User of Apple mobile device Exclusion Criteria: Under 18 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Wagner, RN
Phone
858-784-2028
Email
generank@scripps.edu
Facility Information:
Facility Name
Scripps Translational Science Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Spencer, PhD
Email
generank@scripps.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.

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MyGeneRank: A Digital Platform for Next-Generation Genetic Studies

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