<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/NCT03792659</url>
  </required_header>
  <id_info>
    <org_study_id>1602017284</org_study_id>
    <nct_id>NCT03792659</nct_id>
  </id_info>
  <brief_title>The EXPLORE MG Registry for Myasthenia Gravis</brief_title>
  <official_title>Exploring Outcomes and Characteristics of Myasthenia Gravis: The EXPLORE MG Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</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 create a Yale University Department of Neurology Myasthenia&#xD;
      Gravis (MG) registry that will be used for current and future research projects involving the&#xD;
      study of Myasthenia Gravis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This registry will allow for the research of several mechanisms of Myasthenia Gravis (MG) by&#xD;
      studying peripheral blood, stool, disease status and course, and treatment of subjects with&#xD;
      MG. The EXPLORE-MG Registry focuses on varied aspects of MG such as disease management,&#xD;
      health care utilization, health costs, disease characteristics, and diagnostic tools. As&#xD;
      such, it will aid in a broader understanding of MG, while providing a registry from which&#xD;
      questions about the disease may be better answered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 30, 2016</start_date>
  <completion_date type="Anticipated">October 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>8 Years</target_duration>
  <primary_outcome>
    <measure>The number of successful blood draws will be reported at the conclusion of the sample collection</measure>
    <time_frame>8 years</time_frame>
    <description>Successful Collection of Blood</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of stool samples collected will be reported at the conclusion of the sample</measure>
    <time_frame>8 years</time_frame>
    <description>Count of Stool Samples</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Myasthenia Gravis</condition>
  <arm_group>
    <arm_group_label>Neurological Outpatients</arm_group_label>
    <description>Participants in this group will be recruited from the outpatient clinical population at the Yale University Department of Neurology. Treating physicians will make the initial determination of patients' potential eligibility to participate in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Sample Draw</intervention_name>
    <description>Approximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups.</description>
    <arm_group_label>Neurological Outpatients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      100 cc (less than 1/2 cup) of blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be 18 years of age or older with a clinical diagnosis of a Myasthenia Gravis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients diagnosed with Myasthenia Gravis presenting to the Yale Department of&#xD;
             Neurology for clinical care or research interventions will be invited to donate their&#xD;
             biological specimens/clinical data.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to meet the Inclusion Criteria.&#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>Richard Nowak, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor, Yale University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bailey Sheldon, PhD</last_name>
    <phone>203-737-7095</phone>
    <email>bailey.munrosheldon@yale.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yale-New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bailey Munro Sheldon, PhD</last_name>
      <phone>203-737-7095</phone>
      <email>bailey.munrosheldon@yale.edu</email>
    </contact>
    <investigator>
      <last_name>Richard Nowak, MD, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Anil R, Kumar A, Alaparthi S, Sharma A, Nye JL, Roy B, O'Connor KC, Nowak RJ. Exploring outcomes and characteristics of myasthenia gravis: Rationale, aims and design of registry - The EXPLORE-MG registry. J Neurol Sci. 2020 Jul 15;414:116830. doi: 10.1016/j.jns.2020.116830. Epub 2020 Apr 16.</citation>
    <PMID>32388060</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</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>Myasthenia Gravis</mesh_term>
    <mesh_term>Muscle Weakness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03792659
org study id: 1602017284
nct id: NCT03792659
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to create a Yale University Department of Neurology Myasthenia
      Gravis (MG) registry that will be used for current and future research projects involving the
      study of Myasthenia Gravis.
This registry will allow for the research of several mechanisms of Myasthenia Gravis (MG) by
      studying peripheral blood, stool, disease status and course, and treatment of subjects with
      MG. The EXPLORE-MG Registry focuses on varied aspects of MG such as disease management,
      health care utilization, health costs, disease characteristics, and diagnostic tools. As
      such, it will aid in a broader understanding of MG, while providing a registry from which
      questions about the disease may be better answered.
observational model: Other
time perspective: Other
measure: The number of successful blood draws will be reported at the conclusion of the sample collection
time frame: 8 years
description: Successful Collection of Blood
measure: The number of stool samples collected will be reported at the conclusion of the sample
time frame: 8 years
description: Count of Stool Samples
arm group label: Neurological Outpatients
description: Participants in this group will be recruited from the outpatient clinical population at the Yale University Department of Neurology. Treating physicians will make the initial determination of patients' potential eligibility to participate in the study.
intervention type: Other
intervention name: Blood Sample Draw
description: Approximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups.
arm group label: Neurological Outpatients
100 cc (less than 1/2 cup) of blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Nowak, MD, MS
role: Principal Investigator
affiliation: Assistant Professor, Yale University
last name: Bailey Sheldon, PhD
phone: 203-737-7095
email: bailey.munrosheldon@yale.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Anil R, Kumar A, Alaparthi S, Sharma A, Nye JL, Roy B, O'Connor KC, Nowak RJ. Exploring outcomes and characteristics of myasthenia gravis: Rationale, aims and design of registry - The EXPLORE-MG registry. J Neurol Sci. 2020 Jul 15;414:116830. doi: 10.1016/j.jns.2020.116830. Epub 2020 Apr 16.
PMID: 32388060
responsible party type: Sponsor
mesh term: Myasthenia Gravis
mesh term: Muscle Weakness
sharing ipd: No