<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/NCT02994121</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16050143/STUDY19080007</org_study_id>
    <nct_id>NCT02994121</nct_id>
  </id_info>
  <brief_title>Prospective Investigation of Multiple Sclerosis in the Three Rivers Region</brief_title>
  <acronym>PROMOTE</acronym>
  <official_title>Prospective Investigation of Multiple Sclerosis in the Three Rivers Region</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this longitudinal prospective natural history study of multiple sclerosis (MS), the&#xD;
      overarching goal is to understand the factors that influence individual variation in disease&#xD;
      trajectory and treatment response and pave the way for realizing precision medicine in MS.&#xD;
      Because MS is a chronic neurological disorder, this observational cohort study will span a&#xD;
      30-year time frame.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Activities: Initial Questionnaire, Questionnaire for Self-Reported Outcomes,&#xD;
      Biological Sample Collection (Blood, Stool, Urine, Cerebrospinal fluid), Genetic Analysis,&#xD;
      Standard Quantitative Assessment of Function, Cognitive Assessment, Neuroimaging, Biometric&#xD;
      Sensors, Social Network Questionnaire, Connor-Davidson Resilience Scale, NEO Five-Factor&#xD;
      Inventory, and the COVID19 Response Surveys.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">January 2047</completion_date>
  <primary_completion_date type="Anticipated">January 2047</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>Establish a prospective cohort of well-characterized MS patients and controls</measure>
    <time_frame>within 30 years</time_frame>
    <description>For this longitudinal prospective observational study, we will establish a prospective cohort of well-characterized MS patients and controls (2:1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigate the predictors of the variations in disease trajectory and treatment response</measure>
    <time_frame>within 30 years</time_frame>
    <description>Understanding the factors that influence disease trajectory and treatment response will pave the way to realize precision medicine in delivering individualized MS care.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">7500</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>People with Multiple Sclerosis or Related Disorders</arm_group_label>
    <description>Individuals must be 7 years or older, diagnosed with multiple sclerosis or related disorders, including a first central nervous system demyelinating episode with a positive MRI scan or abnormal MRI scans characteristic of MS but no clinical symptoms of the disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>People without Multiple Sclerosis or Related Disorders</arm_group_label>
    <description>Control participants must be 7 years or older, have no known personal history of multiple sclerosis or related disorders, no other chronic disease, and can be a family member, unrelated household control, or control from the general population.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, stool, urine, saliva, and cerebrospinal fluid collection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        People with multiple sclerosis and related disorders and controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria for MS patients include:&#xD;
&#xD;
               1. willing and able to give consent&#xD;
&#xD;
               2. age 7 years or older&#xD;
&#xD;
               3. diagnosis of multiple sclerosis or related disorders, including a first central&#xD;
                  nervous system demyelinating episode with a positive MRI scan or abnormal MRI&#xD;
                  scans characteristic of MS but no clinical symptoms of the disease&#xD;
&#xD;
          -  For healthy controls:&#xD;
&#xD;
               1. Age 7 years or older&#xD;
&#xD;
               2. Willing and able to provide consent (for &gt;=18 years) or assent with permission&#xD;
                  from at least one of the child's parents (for &lt;18 years)&#xD;
&#xD;
               3. No known personal history of multiple sclerosis or related disorders&#xD;
&#xD;
               4. No other chronic diseases&#xD;
&#xD;
               5. Family members, unrelated household controls, or controls from the general&#xD;
                  population could be eligible&#xD;
&#xD;
        There is no exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zongqi Xia, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zongqi Xia, MD, PhD</last_name>
    <phone>412-383-5377</phone>
    <email>msstudy2@pitt.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zongqi Xia, MD, PhD</last_name>
      <phone>412-383-5377</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 9, 2022</last_update_submitted>
  <last_update_submitted_qc>December 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Zongqi Xia</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <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/NCT02994121
org study id: PRO16050143/STUDY19080007
nct id: NCT02994121
lead sponsor: 
has dmc: Yes
In this longitudinal prospective natural history study of multiple sclerosis (MS), the
      overarching goal is to understand the factors that influence individual variation in disease
      trajectory and treatment response and pave the way for realizing precision medicine in MS.
      Because MS is a chronic neurological disorder, this observational cohort study will span a
      30-year time frame.
Research Activities: Initial Questionnaire, Questionnaire for Self-Reported Outcomes,
      Biological Sample Collection (Blood, Stool, Urine, Cerebrospinal fluid), Genetic Analysis,
      Standard Quantitative Assessment of Function, Cognitive Assessment, Neuroimaging, Biometric
      Sensors, Social Network Questionnaire, Connor-Davidson Resilience Scale, NEO Five-Factor
      Inventory, and the COVID19 Response Surveys.
observational model: Cohort
time perspective: Prospective
measure: Establish a prospective cohort of well-characterized MS patients and controls
time frame: within 30 years
description: For this longitudinal prospective observational study, we will establish a prospective cohort of well-characterized MS patients and controls (2:1).
measure: Investigate the predictors of the variations in disease trajectory and treatment response
time frame: within 30 years
description: Understanding the factors that influence disease trajectory and treatment response will pave the way to realize precision medicine in delivering individualized MS care.
arm group label: People with Multiple Sclerosis or Related Disorders
description: Individuals must be 7 years or older, diagnosed with multiple sclerosis or related disorders, including a first central nervous system demyelinating episode with a positive MRI scan or abnormal MRI scans characteristic of MS but no clinical symptoms of the disease
arm group label: People without Multiple Sclerosis or Related Disorders
description: Control participants must be 7 years or older, have no known personal history of multiple sclerosis or related disorders, no other chronic disease, and can be a family member, unrelated household control, or control from the general population.
Blood, stool, urine, saliva, and cerebrospinal fluid collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zongqi Xia, MD, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: Zongqi Xia, MD, PhD
phone: 412-383-5377
email: msstudy2@pitt.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Zongqi Xia
investigator title: MD, PhD
mesh term: Multiple Sclerosis
mesh term: Sclerosis