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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

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 11, 2017
Last Update Posted Date March 18, 2021
Actual Study Start Date  ICMJE September 26, 2017
Estimated Primary Completion Date September 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
Initiation of Statin Therapy [ Time Frame: 6 months ]
Participant begins taking Statin as indicated by survey.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MyGeneRank: A Digital Platform for Next-Generation Genetic Studies
Official Title  ICMJE MyGeneRank: A Digital Platform for Next-Generation Genetic Studies
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Heart Diseases
Intervention  ICMJE Other: Receive genetic risk information
Risk scores are provided by ResearchKit app.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2017)
100000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2030
Estimated Primary Completion Date September 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18 years old
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jennifer Wagner, RN 858-784-2028 generank@scripps.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03277365
Other Study ID Numbers  ICMJE 16-6835
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared.
Current Responsible Party Ali Torkamani, Scripps Translational Science Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Scripps Translational Science Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Scripps Translational Science Institute
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP