<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/NCT01723709</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00023791</org_study_id>
    <nct_id>NCT01723709</nct_id>
  </id_info>
  <brief_title>The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort</brief_title>
  <official_title>The MURDOCK Study Community Registry and Biorepository Multiple Sclerosis Cohort</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 goal of this study is to enroll 1000 participants with a history of Multiple Sclerosis&#xD;
      into the MURDOCK Study (Duke IRB Pro00011196) as well as into the Multiple Sclerosis Cohort&#xD;
      study (Duke IRB Pro00023791). All 1000 participants will answer a 4-page questionnaire&#xD;
      administered by a trained study coordinator which is designed to collect information on the&#xD;
      participant's diagnosis of Multiple Sclerosis. The goal of the study is to seek genetic&#xD;
      explanations for response to treatment, progression of the disease, and biomarker validation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite tremendous research efforts, the targets of immune response and the mechanisms for&#xD;
      neuronal loss associated with MS have not been fully characterized. Although substantial&#xD;
      advances have been made in the development of therapeutic treatments, the drugs currently&#xD;
      available to MS patients do not significantly alter the long-term prognosis of the disease.&#xD;
      Better markers that represent the biological activity of the disease process and response to&#xD;
      therapy are desperately needed. MS is thought to be mediated by autoimmunity which causes&#xD;
      demyelination and transection of axons throughout the brain and spinal cord resulting in the&#xD;
      formation of multiple scars (or scleroses) on axon myelin sheaths and reducing electrical&#xD;
      conductivity and decreased CNS signaling. It is most common in young adults; more than 90% of&#xD;
      patients are diagnosed before the age of 55 and less than 5% before the age of 14. Females&#xD;
      are 2-3 times more frequently affected than males and children of affected females are at a&#xD;
      significantly higher risk of developing MS than children of affected males. A strong genetic&#xD;
      component is suggested by the co-occurrence of cases within families and the high disease&#xD;
      prevalence in some ethnic populations (particularly those of northern European origin)&#xD;
      compared with others (African and Asian groups) irrespective of geographic location.7 The&#xD;
      incidence of MS in northern Europe, where the genetically associated haplotype HLA DR2 is&#xD;
      most common, is as high as 1 per 750 individuals. MS affects more than 400,000 people in the&#xD;
      U.S. and 2.5 million worldwide.&#xD;
&#xD;
      Although numerous putative MS-specific biomarkers, representing different mechanisms of&#xD;
      pathogenesis and steps along the inflammatory cascade have been proposed, none have been&#xD;
      fully validated. To date, the majority of studies identifying biomarkers associated with MS&#xD;
      initiation or progression have been limited to investigation of one to several markers at a&#xD;
      time; only one study has attempted open platform proteomic profiling in MS; however, the&#xD;
      study size was relatively small and the clinical homogeneity of the dataset of the study is&#xD;
      not clear. To understand a complex disease like MS, high throughput technologies capable of&#xD;
      profiling multiple etiological changes is needed as well as a well-define population of those&#xD;
      with the disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Serum-based proteomic biomarkers associated with disease initiation and progression in MS</measure>
    <time_frame>5 years</time_frame>
    <description>Biological material (serum, urine, whole blood and Paxgene RNA) collected in the MURDOCK Study(Pro00011196) will permit the initiation of a biomarker discovery project for all patients consented under the MS cohort protocol. Participants in this study will be followed for 5 years after consent with additional blood draws and questionnaires occurring biannually during this period.</description>
  </primary_outcome>
  <enrollment type="Actual">973</enrollment>
  <condition>Multiple Sclerosis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      7.5 mL PaxGene RNA collection 6 mL DNA whole blood collection 40 mL urine collection 20 mL&#xD;
      serum SST tube collection 16 mL plasma EDTA tube collection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants must enroll or have enrolled in the MURDOCK Study Community Registry and&#xD;
        Biorepository prior to joining the Multiple Sclerosis Cohort. At the MURDOCK Study visit,&#xD;
        or after the participant has enrolled in the MURDOCK Study, they will be asked (either in&#xD;
        person or via the phone) if they would be willing to join the Multiple Sclerosis cohort&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Multiple Sclerosis Diagnosis or self report Multiple Sclerosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who are not willing to participate in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simon Gregory, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Medicine Site Based Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carolinas Medical Center Northeast Medical Arts Building</name>
      <address>
        <city>Concord</city>
        <state>North Carolina</state>
        <zip>28025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ada Jenkins Center</name>
      <address>
        <city>Davidson</city>
        <state>North Carolina</state>
        <zip>28036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Stedman Center on the Duke Center for Living Campus</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kannapolis Internal Medicine</name>
      <address>
        <city>Kannapolis</city>
        <state>North Carolina</state>
        <zip>28081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raleigh Neurology Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>July 18, 2017</last_update_submitted>
  <last_update_submitted_qc>July 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multiple sclerosis</keyword>
  <keyword>immune response</keyword>
  <keyword>genetic</keyword>
  <keyword>progression</keyword>
  <keyword>relapse</keyword>
  <keyword>biomarkers</keyword>
  <keyword>disease</keyword>
  <keyword>proteomics</keyword>
  <keyword>genome</keyword>
  <keyword>gene</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT01723709
org study id: Pro00023791
nct id: NCT01723709
lead sponsor: 
has dmc: Yes
The goal of this study is to enroll 1000 participants with a history of Multiple Sclerosis
      into the MURDOCK Study (Duke IRB Pro00011196) as well as into the Multiple Sclerosis Cohort
      study (Duke IRB Pro00023791). All 1000 participants will answer a 4-page questionnaire
      administered by a trained study coordinator which is designed to collect information on the
      participant's diagnosis of Multiple Sclerosis. The goal of the study is to seek genetic
      explanations for response to treatment, progression of the disease, and biomarker validation.
Despite tremendous research efforts, the targets of immune response and the mechanisms for
      neuronal loss associated with MS have not been fully characterized. Although substantial
      advances have been made in the development of therapeutic treatments, the drugs currently
      available to MS patients do not significantly alter the long-term prognosis of the disease.
      Better markers that represent the biological activity of the disease process and response to
      therapy are desperately needed. MS is thought to be mediated by autoimmunity which causes
      demyelination and transection of axons throughout the brain and spinal cord resulting in the
      formation of multiple scars (or scleroses) on axon myelin sheaths and reducing electrical
      conductivity and decreased CNS signaling. It is most common in young adults; more than 90% of
      patients are diagnosed before the age of 55 and less than 5% before the age of 14. Females
      are 2-3 times more frequently affected than males and children of affected females are at a
      significantly higher risk of developing MS than children of affected males. A strong genetic
      component is suggested by the co-occurrence of cases within families and the high disease
      prevalence in some ethnic populations (particularly those of northern European origin)
      compared with others (African and Asian groups) irrespective of geographic location.7 The
      incidence of MS in northern Europe, where the genetically associated haplotype HLA DR2 is
      most common, is as high as 1 per 750 individuals. MS affects more than 400,000 people in the
      U.S. and 2.5 million worldwide.

      Although numerous putative MS-specific biomarkers, representing different mechanisms of
      pathogenesis and steps along the inflammatory cascade have been proposed, none have been
      fully validated. To date, the majority of studies identifying biomarkers associated with MS
      initiation or progression have been limited to investigation of one to several markers at a
      time; only one study has attempted open platform proteomic profiling in MS; however, the
      study size was relatively small and the clinical homogeneity of the dataset of the study is
      not clear. To understand a complex disease like MS, high throughput technologies capable of
      profiling multiple etiological changes is needed as well as a well-define population of those
      with the disease.
observational model: Cohort
time perspective: Prospective
measure: Serum-based proteomic biomarkers associated with disease initiation and progression in MS
time frame: 5 years
description: Biological material (serum, urine, whole blood and Paxgene RNA) collected in the MURDOCK Study(Pro00011196) will permit the initiation of a biomarker discovery project for all patients consented under the MS cohort protocol. Participants in this study will be followed for 5 years after consent with additional blood draws and questionnaires occurring biannually during this period.
7.5 mL PaxGene RNA collection 6 mL DNA whole blood collection 40 mL urine collection 20 mL
      serum SST tube collection 16 mL plasma EDTA tube collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Gregory, PhD
role: Principal Investigator
affiliation: Duke Medicine Site Based Research Group
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis