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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Other: Receive genetic risk information
Risk scores are provided by ResearchKit app.
- Initiation of Statin Therapy [ Time Frame: 6 months ]Participant begins taking Statin as indicated by survey.
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
|Contact: Jennifer Wagner, RNemail@example.com|
|United States, California|
|Scripps Translational Science Institute||Recruiting|
|La Jolla, California, United States, 92037|
|Contact: Emily Spencer, PhD firstname.lastname@example.org|