<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/NCT01688986</url>
  </required_header>
  <id_info>
    <org_study_id>120194</org_study_id>
    <secondary_id>12-E-0194</secondary_id>
    <nct_id>NCT01688986</nct_id>
  </id_info>
  <brief_title>Environmental Polymorphisms Registry Health and Exposures Survey</brief_title>
  <official_title>Environmental Polymorphisms Registry Health and Exposures Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Environmental Health Sciences (NIEHS)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      The Environmental Polymorphisms Registry (EPR) Health and Exposure Survey is designed to&#xD;
      gather health, family history of disease, environmental exposures and lifestyle data on adult&#xD;
      EPR subjects. The EPR is a registry established to collect and store DNA samples from 20,000&#xD;
      volunteers from North Carolina and to serve as a resource to scientist investigating&#xD;
      genotype-driven translational research of chronic conditions. Under this new protocol, we&#xD;
      will administer a health and exposures survey to all EPR subjects. The information collected&#xD;
      in the survey will be used to better characterize the EPR population thus making it more&#xD;
      useful to NIEHS researchers. The survey contains approximately 200 questions. Data from the&#xD;
      survey will help researchers develop hypotheses, design follow-up studies, and select&#xD;
      appropriate subjects.&#xD;
&#xD;
      The survey will be administered to EPR subjects using a modified version of the Dillman Total&#xD;
      Design Method (TDM) for surveys. This method requires following specific time-dependent steps&#xD;
      for survey administration that incorporate both self- and phone administration and other&#xD;
      types of phone and mail contact. The goal of TDM is to maximize subject response rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Environmental Polymorphisms Registry (EPR) Health and Exposure Survey is designed to&#xD;
      collect health, family history of disease, environmental exposures and lifestyle data on EPR&#xD;
      participants. The EPR was established to collect and store DNA specimens from 20,000&#xD;
      participants and to serve as a resource for scientists investigating genotype-driven&#xD;
      translational research of chronic health conditions. Under this protocol, we will administer&#xD;
      the approximately 200 question Health and Exposure Survey to EPR participants. The&#xD;
      information will be used to better characterize the EPR population, thus making it more&#xD;
      useful in answering research questions related to gene-environment interactions. Data from&#xD;
      the survey will help researchers to advance clinical research by developing new ways of&#xD;
      preventing, diagnosing, and treating common diseases such as cardiovascular disease, asthma,&#xD;
      and diabetes.&#xD;
&#xD;
      During Phases I and II, the survey was administered to EPR participants using a modified&#xD;
      version of the Dillman Total Design Method (TDM) for surveys. This method requires following&#xD;
      specific steps for survey administration that incorporate web-based, paper and phone&#xD;
      administration. The rationale for using the TDM is to maximize participant response rates.&#xD;
      During Phase III, the survey may be distributed to new EPR participants (e.g., those who were&#xD;
      not enrolled in the EPR at the time of the Phase I and II survey administrations) for&#xD;
      self-administration at the time of enrollment.&#xD;
&#xD;
      Investigators may select and contact participants for follow-up studies based upon health,&#xD;
      exposure, or disease status information; this includes responses to the EPR Health and&#xD;
      Exposure Survey. Participation in follow-up studies is completely voluntary. Participants can&#xD;
      decide at the time they are contacted if they would like to enroll in the follow-up study.&#xD;
      Their decision whether or not to participate in a follow-up study will not affect their&#xD;
      participation in the EPR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 25, 2012</start_date>
  <completion_date>November 22, 2016</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">9000</enrollment>
  <condition>Diabetes</condition>
  <condition>Heart Disease</condition>
  <condition>Asthma</condition>
  <eligibility>
    <criteria>
      <textblock>
        -  ELIGIBILITY CRITERIA:&#xD;
&#xD;
        There are no clinical exclusion criteria for this Survey. All subjects will be administered&#xD;
        the Survey regardless of having clinical conditions.&#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_official>
    <last_name>Shepherd H Schurman, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Environmental Health Sciences (NIEHS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NIEHS Clinical Research Unit (CRU)</name>
      <address>
        <city>Research Triangle Park</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 22, 2016</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>August 29, 2018</last_update_submitted>
  <last_update_submitted_qc>August 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Complex Disease</keyword>
  <keyword>DNA Biorepository</keyword>
  <keyword>Genotype-Phenotype Correlation</keyword>
  <keyword>Genetics</keyword>
  <keyword>Environmental Factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT01688986
org study id: 120194
secondary id: 12-E-0194
nct id: NCT01688986
lead sponsor: 
The Environmental Polymorphisms Registry (EPR) Health and Exposure Survey is designed to
      gather health, family history of disease, environmental exposures and lifestyle data on adult
      EPR subjects. The EPR is a registry established to collect and store DNA samples from 20,000
      volunteers from North Carolina and to serve as a resource to scientist investigating
      genotype-driven translational research of chronic conditions. Under this new protocol, we
      will administer a health and exposures survey to all EPR subjects. The information collected
      in the survey will be used to better characterize the EPR population thus making it more
      useful to NIEHS researchers. The survey contains approximately 200 questions. Data from the
      survey will help researchers develop hypotheses, design follow-up studies, and select
      appropriate subjects.

      The survey will be administered to EPR subjects using a modified version of the Dillman Total
      Design Method (TDM) for surveys. This method requires following specific time-dependent steps
      for survey administration that incorporate both self- and phone administration and other
      types of phone and mail contact. The goal of TDM is to maximize subject response rates.
The Environmental Polymorphisms Registry (EPR) Health and Exposure Survey is designed to
      collect health, family history of disease, environmental exposures and lifestyle data on EPR
      participants. The EPR was established to collect and store DNA specimens from 20,000
      participants and to serve as a resource for scientists investigating genotype-driven
      translational research of chronic health conditions. Under this protocol, we will administer
      the approximately 200 question Health and Exposure Survey to EPR participants. The
      information will be used to better characterize the EPR population, thus making it more
      useful in answering research questions related to gene-environment interactions. Data from
      the survey will help researchers to advance clinical research by developing new ways of
      preventing, diagnosing, and treating common diseases such as cardiovascular disease, asthma,
      and diabetes.

      During Phases I and II, the survey was administered to EPR participants using a modified
      version of the Dillman Total Design Method (TDM) for surveys. This method requires following
      specific steps for survey administration that incorporate web-based, paper and phone
      administration. The rationale for using the TDM is to maximize participant response rates.
      During Phase III, the survey may be distributed to new EPR participants (e.g., those who were
      not enrolled in the EPR at the time of the Phase I and II survey administrations) for
      self-administration at the time of enrollment.

      Investigators may select and contact participants for follow-up studies based upon health,
      exposure, or disease status information; this includes responses to the EPR Health and
      Exposure Survey. Participation in follow-up studies is completely voluntary. Participants can
      decide at the time they are contacted if they would like to enroll in the follow-up study.
      Their decision whether or not to participate in a follow-up study will not affect their
      participation in the EPR.
observational model: Cohort
time perspective: Retrospective
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shepherd H Schurman, M.D.
role: Principal Investigator
affiliation: National Institute of Environmental Health Sciences (NIEHS)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Diseases