<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/NCT03004794</url>
  </required_header>
  <id_info>
    <org_study_id>RC4</org_study_id>
    <nct_id>NCT03004794</nct_id>
  </id_info>
  <brief_title>Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <brief_summary>
    <textblock>
      Initial recruitment: 1717, 136 (7.92%) were excluded due to missing data that could not be&#xD;
      obtained. The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision&#xD;
      of the McDonald criteria.&#xD;
&#xD;
      Patients analyses: 1581 Every patient was registered by his/her 14-digit unique identity&#xD;
      numbers, (which is mandatory in Egypt since 1999) to make sure that every registered patient&#xD;
      in different centers were counted only once.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients' records review procedure and sampling strategies. The medical records,&#xD;
      administrative data, laboratory and diagnostic tests reports were screened by 3 authors (HS,&#xD;
      NS, AE) and these data were extracted in a standard electronic form according to Kasr Alaini&#xD;
      Multiple Sclerosis Unit (KAMSU) registry.&#xD;
&#xD;
      An assigned coordinator from each center was requested to facilitate data collection from&#xD;
      site-specific records. In cases of incomplete documentation or unclear information,&#xD;
      verification was done by on-site data coordinator either by phone contact or face-to-face&#xD;
      interview with the patients, whether during the routine follow up or in an unscheduled visit.&#xD;
&#xD;
      Several measures were taken to ensure the confidentiality of the collected information. No&#xD;
      patient names were included in the database presented by site coordinator, and the study&#xD;
      staff signed a confidentiality agreement for non-disclosure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evoked Potentials (measure latency in m.sec)</measure>
    <time_frame>13 months (through study completion)</time_frame>
    <description>Number of patients with delayed latency of Evoked Potentials</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cerebrospinal Fluid (CSF): measure IgG index and Oligoclonal bands (OCB)</measure>
    <time_frame>13 months (through study completion)</time_frame>
    <description>Number of patients with elevated IgG index and OCB</description>
  </primary_outcome>
  <enrollment type="Actual">1581</enrollment>
  <condition>Multiple Sclerosis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>medical records review</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision of the&#xD;
        McDonald criteria, and patients were classified according to the course of the disease into&#xD;
        relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis&#xD;
        (SPMS) and primary-progressive multiple sclerosis (PPMS). Patients with first demyelinating&#xD;
        event, before 2010, were re-assessed by on-site coordinators to label them clinically&#xD;
        isolated syndrome (CIS), whenever applicable, according to McDonalds 2010, and&#xD;
        neuromyelitis optica (NMO) cases diagnosis was verified according to the 2015 diagnostic&#xD;
        criteria. Those with typical brain Magnetic Resonant Imaging (MRI) MS like lesions without&#xD;
        related clinical manifestations were diagnosed as radiologically isolated syndrome (RIS).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with suspecting multiple sclerosis attending 4 tertiary referral centers&#xD;
             in Egypt&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  missing data that could not be obtained&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hatem Samir Shehata</investigator_full_name>
    <investigator_title>Professor of Neurology</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/NCT03004794
org study id: RC4
nct id: NCT03004794
lead sponsor: 
Initial recruitment: 1717, 136 (7.92%) were excluded due to missing data that could not be
      obtained. The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision
      of the McDonald criteria.

      Patients analyses: 1581 Every patient was registered by his/her 14-digit unique identity
      numbers, (which is mandatory in Egypt since 1999) to make sure that every registered patient
      in different centers were counted only once.
Patients' records review procedure and sampling strategies. The medical records,
      administrative data, laboratory and diagnostic tests reports were screened by 3 authors (HS,
      NS, AE) and these data were extracted in a standard electronic form according to Kasr Alaini
      Multiple Sclerosis Unit (KAMSU) registry.

      An assigned coordinator from each center was requested to facilitate data collection from
      site-specific records. In cases of incomplete documentation or unclear information,
      verification was done by on-site data coordinator either by phone contact or face-to-face
      interview with the patients, whether during the routine follow up or in an unscheduled visit.

      Several measures were taken to ensure the confidentiality of the collected information. No
      patient names were included in the database presented by site coordinator, and the study
      staff signed a confidentiality agreement for non-disclosure.
observational model: Case-Only
time perspective: Retrospective
measure: Evoked Potentials (measure latency in m.sec)
time frame: 13 months (through study completion)
description: Number of patients with delayed latency of Evoked Potentials
measure: Cerebrospinal Fluid (CSF): measure IgG index and Oligoclonal bands (OCB)
time frame: 13 months (through study completion)
description: Number of patients with elevated IgG index and OCB
intervention type: Other
intervention name: medical records review
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 60 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hatem Samir Shehata
investigator title: Professor of Neurology
mesh term: Multiple Sclerosis
mesh term: Sclerosis