<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/NCT01708408</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00011196</org_study_id>
    <nct_id>NCT01708408</nct_id>
  </id_info>
  <brief_title>The MURDOCK Study Registry and Biorepository Horizon 1.5</brief_title>
  <acronym>MURDOCK</acronym>
  <official_title>Measurement to Understand Reclassification of Disease of Cabarrus/Kannapolis The MURDOCK Study Registry and Biorepository Horizon 1.5</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MURDOCK Study Community Registry and Biorepository (Horizon 1.5) aims to create a&#xD;
      large-scale community registry and biorepository that can be used as a vehicle for future&#xD;
      health services, epidemiologic, clinical trials and other omics-related research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MURDOCK Study Community Registry and Biorepository's activities include enrolling&#xD;
      approximately 50,000 participants who live in Cabarrus County and/or Kannapolis, North&#xD;
      Carolina. Participants must consent to (1) use of the data provided by the participant&#xD;
      through completion of the Participant Registry Questionnaire for epidemiologic population&#xD;
      characterization, (2) annual contact to update their MURDOCK Horizon 1.5 database record, (3)&#xD;
      release of their medical information, including but not limited to demographic information,&#xD;
      problem lists, medications, social and family history, and results of laboratory and other&#xD;
      testing modalities from pre-existing paper or electronic health records or electronic health&#xD;
      records that may become available in the future, (4) provision of a blood and urine sample,&#xD;
      and (5) contact up to four times/year to request participation in additional research&#xD;
      studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 2009</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The MURDOCK Study Registry and Biorepository Horizon 1.5</measure>
    <time_frame>Upto 119 months</time_frame>
    <description>To provide information for large-scale epidemiologic and clinical translational research and the research infrastructure to identify specific phenotypes and outcomes to improve medicine</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50000</enrollment>
  <condition>Chronic Disease</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>community</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Biomarker studies</intervention_name>
    <arm_group_label>community</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, 25 mL (whole blood, plasma, serum, buffy coat, PAXgene); Urine, 36 mL&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The Community Registry and Biorepository is designed to create a community registry and&#xD;
        biorepository populated by approximately 50,000 residents of Cabarrus County and/or the&#xD;
        city of Kannapolis in North Carolina.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A resident of Cabarrus County and/or the city of Kannapolis (and surrounding regions)&#xD;
             for 6 or more months of the year&#xD;
&#xD;
          2. At least 18 years of age&#xD;
&#xD;
          3. Able to understand and give written informed consent, or have a legal guardian or&#xD;
             caregiver present to give informed consent by proxy (assent from a participant between&#xD;
             ages 12-18 will be obtained when their parent or legal guardian consents on their&#xD;
             behalf).&#xD;
&#xD;
          4. Willing and able to participate in all 5 components of the registry and biorepository&#xD;
             as described above in Section III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. There are no exclusions to participation if all inclusion criteria have been met.&#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>Kristin M Newby, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Clinical Translational Science Institute-MURDOCK Study</name>
      <address>
        <city>Kannapolis</city>
        <state>North Carolina</state>
        <zip>28081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.murdock-study.org</url>
    <description>MURDOCK Study website</description>
  </link>
  <reference>
    <citation>Tenenbaum JD, Christian V, Cornish MA, Dolor RJ, Dunham AA, Ginsburg GS, Kraus VB, McHutchison JG, Nahm ML, Newby LK, Svetkey LP, Udayakumar K, Califf RM. The MURDOCK Study: a long-term initiative for disease reclassification through advanced biomarker discovery and integration with electronic health records. Am J Transl Res. 2012;4(3):291-301. Epub 2012 Jul 23.</citation>
    <PMID>22937207</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biorepository</keyword>
  <keyword>biobank</keyword>
  <keyword>registry</keyword>
  <keyword>community</keyword>
  <keyword>biospecimens</keyword>
  <keyword>volunteers</keyword>
  <keyword>chronic disease</keyword>
  <keyword>longitudinal</keyword>
  <keyword>blood</keyword>
  <keyword>electronic health records</keyword>
  <keyword>follow-up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</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/NCT01708408
org study id: Pro00011196
nct id: NCT01708408
lead sponsor: 
has dmc: Yes
The MURDOCK Study Community Registry and Biorepository (Horizon 1.5) aims to create a
      large-scale community registry and biorepository that can be used as a vehicle for future
      health services, epidemiologic, clinical trials and other omics-related research.
The MURDOCK Study Community Registry and Biorepository's activities include enrolling
      approximately 50,000 participants who live in Cabarrus County and/or Kannapolis, North
      Carolina. Participants must consent to (1) use of the data provided by the participant
      through completion of the Participant Registry Questionnaire for epidemiologic population
      characterization, (2) annual contact to update their MURDOCK Horizon 1.5 database record, (3)
      release of their medical information, including but not limited to demographic information,
      problem lists, medications, social and family history, and results of laboratory and other
      testing modalities from pre-existing paper or electronic health records or electronic health
      records that may become available in the future, (4) provision of a blood and urine sample,
      and (5) contact up to four times/year to request participation in additional research
      studies.
observational model: Other
time perspective: Prospective
measure: The MURDOCK Study Registry and Biorepository Horizon 1.5
time frame: Upto 119 months
description: To provide information for large-scale epidemiologic and clinical translational research and the research infrastructure to identify specific phenotypes and outcomes to improve medicine
arm group label: community
intervention type: Genetic
intervention name: Biomarker studies
arm group label: community
Blood, 25 mL (whole blood, plasma, serum, buffy coat, PAXgene); Urine, 36 mL
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kristin M Newby, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
url: http://www.murdock-study.org
description: MURDOCK Study website
citation: Tenenbaum JD, Christian V, Cornish MA, Dolor RJ, Dunham AA, Ginsburg GS, Kraus VB, McHutchison JG, Nahm ML, Newby LK, Svetkey LP, Udayakumar K, Califf RM. The MURDOCK Study: a long-term initiative for disease reclassification through advanced biomarker discovery and integration with electronic health records. Am J Transl Res. 2012;4(3):291-301. Epub 2012 Jul 23.
PMID: 22937207
responsible party type: Sponsor
mesh term: Chronic Disease