<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/NCT03253432</url>
  </required_header>
  <id_info>
    <org_study_id>826438</org_study_id>
    <nct_id>NCT03253432</nct_id>
  </id_info>
  <brief_title>IN-TANDEM Familial Hypercholesterolemia Pilot Study</brief_title>
  <official_title>INTegrating Active Case-finding With Next-generation Sequencing for Diagnosis Through Electronic Medical Records (IN-TANDEM): Familial Hypercholesterolemia Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Familial Hypercholesterolemia Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lancaster General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</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>
      The purpose of this study is to validate the use of the FH Foundation FIND FH® Algorithm as a&#xD;
      clinical decision support tool. FIND FH (Flag/Identify/Network/Engage) is a national&#xD;
      initiative that utilizes machine learning and data mining techniques to identify individuals&#xD;
      whose profiles are consistent with FH patients. The algorithm will be tested in adults with&#xD;
      at least one cardiovascular comorbidity. Study subjects will be asked to provide either a&#xD;
      saliva, buccal or venous blood sample for DNA and biomarker analysis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Actual">November 7, 2018</completion_date>
  <primary_completion_date type="Actual">November 7, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Likelihood of having FH-causing mutation</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of subjects with causative mutation in higher algorithm score groups</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">378</enrollment>
  <condition>Familial Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Strata 0-0.05</arm_group_label>
    <description>Lowest probability of having familial hypercholesterolemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Strata 0.06-0.15</arm_group_label>
    <description>Second lowest probability of having familial hypercholesterolemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Strata 0.16-0.19</arm_group_label>
    <description>Moderate probability of having familial hypercholesterolemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Strata 0.20-0.34</arm_group_label>
    <description>Second highest probability of having familial hypercholesterolemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Strata greater than or equal to 35</arm_group_label>
    <description>Highest probability of having familial hypercholesterolemia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genetic testing</intervention_name>
    <description>Targeted next-generation sequencing for familial hypercholesterolemia causative mutations</description>
    <arm_group_label>Strata 0-0.05</arm_group_label>
    <arm_group_label>Strata 0.06-0.15</arm_group_label>
    <arm_group_label>Strata 0.16-0.19</arm_group_label>
    <arm_group_label>Strata 0.20-0.34</arm_group_label>
    <arm_group_label>Strata greater than or equal to 35</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Randomly selected patients from University of Pennsylvania and Lancaster General Hospital&#xD;
        with at least 1 cardiovascular comorbidity seen at hospital within the past five years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  At least one cardiovascular co-morbidity or receiving treatment for a cardiovascular&#xD;
             comorbidity&#xD;
&#xD;
          -  Algorithm score 0-1&#xD;
&#xD;
          -  Most recent encounter with a provider within five years of query date&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical or psychological conditions that, in the opinion of the investigator,&#xD;
             would compromise the subject's safety or successful participation in the study, or&#xD;
             confound study data&#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>
  <location>
    <facility>
      <name>Lancaster General Hospital</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipoproteinemia Type II</mesh_term>
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data will be shared with other investigators</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>De-identified data will be shared at end of study after database lock</ipd_time_frame>
    <ipd_access_criteria>Research team</ipd_access_criteria>
  </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/NCT03253432
org study id: 826438
nct id: NCT03253432
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to validate the use of the FH Foundation FIND FH® Algorithm as a
      clinical decision support tool. FIND FH (Flag/Identify/Network/Engage) is a national
      initiative that utilizes machine learning and data mining techniques to identify individuals
      whose profiles are consistent with FH patients. The algorithm will be tested in adults with
      at least one cardiovascular comorbidity. Study subjects will be asked to provide either a
      saliva, buccal or venous blood sample for DNA and biomarker analysis
observational model: Cohort
time perspective: Prospective
measure: Likelihood of having FH-causing mutation
time frame: 12 months
description: Proportion of subjects with causative mutation in higher algorithm score groups
arm group label: Strata 0-0.05
description: Lowest probability of having familial hypercholesterolemia
arm group label: Strata 0.06-0.15
description: Second lowest probability of having familial hypercholesterolemia
arm group label: Strata 0.16-0.19
description: Moderate probability of having familial hypercholesterolemia
arm group label: Strata 0.20-0.34
description: Second highest probability of having familial hypercholesterolemia
arm group label: Strata greater than or equal to 35
description: Highest probability of having familial hypercholesterolemia
intervention type: Other
intervention name: Genetic testing
description: Targeted next-generation sequencing for familial hypercholesterolemia causative mutations
arm group label: Strata 0-0.05
arm group label: Strata 0.06-0.15
arm group label: Strata 0.16-0.19
arm group label: Strata 0.20-0.34
arm group label: Strata greater than or equal to 35
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperlipoproteinemia Type II
mesh term: Hypercholesterolemia
sharing ipd: Yes
ipd description: De-identified data will be shared with other investigators
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: De-identified data will be shared at end of study after database lock
ipd access criteria: Research team