<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03277365</url>
  </required_header>
  <id_info>
    <org_study_id>16-6835</org_study_id>
    <nct_id>NCT03277365</nct_id>
  </id_info>
  <brief_title>MyGeneRank: A Digital Platform for Next-Generation Genetic Studies</brief_title>
  <official_title>MyGeneRank: A Digital Platform for Next-Generation Genetic Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scripps Translational Science Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Scripps Translational Science Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many conditions affecting health are caused by a combination of environment, behaviors, and&#xD;
      genes. While individuals can alter some factors in their lives to reduce the chances of&#xD;
      developing different diseases (e.g., not smoking cigarettes), the contribution from genetic&#xD;
      risk encoded by DNA remains with people throughout their lives. Scientists are still trying&#xD;
      to determine the entirety of genetic factors that influence disease, but for some conditions&#xD;
      it has been shown that the factors identified thus far can begin to identify people at high&#xD;
      to low genetic risk. Looking across the genome, scientists can calculate a cumulative genetic&#xD;
      risk score - which can be used to rank genetic risk compared to other worldwide populations.&#xD;
&#xD;
      The goal of this study is to determine how genetic risk influences health decisions and other&#xD;
      things that can be controlled in life. The first genetic risk score is calculated for&#xD;
      coronary heart disease (CAD). CAD ultimately leads to heart attacks, heart failure and&#xD;
      sometimes sudden cardiac death and is the main reason heart disease remains as the number one&#xD;
      cause of death worldwide. Other researchers have shown that this genetic risk score can be&#xD;
      used to identify people with low, intermediate, and high risk for coronary heart disease. It&#xD;
      has also been shown that the use of statins (cholesterol lowering drugs) provides greater&#xD;
      benefit and protection against heart attack for people with high genetic risk for coronary&#xD;
      artery disease.&#xD;
&#xD;
      Leveraging the Apple ResearchKit and the ResearchKit linked 23andMe API, customers of 23andMe&#xD;
      are able to provide researchers access to their genomic data. Participants will use the&#xD;
      ResearchKit app to provide consent, view study information, answer surveys, and contact the&#xD;
      study team.&#xD;
&#xD;
      Participants will be asked to complete 3 surveys. One before viewing genetic risk scores, one&#xD;
      immediately after viewing scores, and one 6 months after viewing scores.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Anticipated">September 2030</completion_date>
  <primary_completion_date type="Actual">February 11, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Initiation of Statin Therapy</measure>
    <time_frame>6 months</time_frame>
    <description>Participant begins taking Statin as indicated by survey.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100000</enrollment>
  <condition>Heart Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Receive genetic risk information</intervention_name>
    <description>Risk scores are provided by ResearchKit app.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Customer of 23andMe willing to share their 23andMe data&#xD;
&#xD;
          -  User of Apple mobile device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jennifer Wagner, RN</last_name>
    <phone>858-784-2028</phone>
    <email>generank@scripps.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Scripps Translational Science Institute</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Spencer, PhD</last_name>
      <email>generank@scripps.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Scripps Translational Science Institute</investigator_affiliation>
    <investigator_full_name>Ali Torkamani</investigator_full_name>
    <investigator_title>Director, Genomics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03277365
org study id: 16-6835
nct id: NCT03277365
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Initiation of Statin Therapy
time frame: 6 months
description: Participant begins taking Statin as indicated by survey.
intervention type: Other
intervention name: Receive genetic risk information
description: Risk scores are provided by ResearchKit app.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Wagner, RN
phone: 858-784-2028
email: generank@scripps.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Scripps Translational Science Institute
investigator full name: Ali Torkamani
investigator title: Director, Genomics
mesh term: Heart Diseases
sharing ipd: No
ipd description: Individual participant data will not be shared.