<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/NCT03244410</url>
  </required_header>
  <id_info>
    <org_study_id>LCITP</org_study_id>
    <nct_id>NCT03244410</nct_id>
  </id_info>
  <brief_title>Lymphocyte Counts in Immune Thrombocytopenic Purpura</brief_title>
  <official_title>Initial Lymphocyte Counts Predictive Value in Immune Thrombocytopenic Purpura</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by&#xD;
           increased platelet destruction and decreased platelet number (cooper N et al 2006)&#xD;
&#xD;
        -  recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial&#xD;
           autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic&#xD;
           forms may represent two distinct immunopathological disorders ( cooper N et al 2006) (&#xD;
           Gern Sheimer T 2009 )&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased&#xD;
      platelet destruction and decreased platelet number ( Cooper N et all 2006) platelet surface&#xD;
      membrane proteins become antigenic for unknown reasons, leading to stimulation of the immune&#xD;
      system, auto antibodies production and platelet destruction ( Gasbarrini A et all 2000) It is&#xD;
      associated with the production of auto antibodies directed against platelet glycoprotein&#xD;
      complex 2b/3a and/or 1b/1x , resulting in accelerated destruction of platelets by the&#xD;
      reticular endothelial system via the activity of Fcc receptor bearing phagocytic cells (&#xD;
      Provan &amp; Newland et al 2002) Recent studies have demonstrated that the pathogenesis of ITP&#xD;
      envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that&#xD;
      acute and chronic forms may represent two distinct immunopathological disorders ( Cooper N et&#xD;
      al 2006) ( Gern Sheimer T 2009)&#xD;
&#xD;
      There are many phases of the disease:&#xD;
&#xD;
        1. Newly diagnosed ITP : for all cases at diagnosis.&#xD;
&#xD;
        2. persistent ITP: for patients with ITP between 3 to 12 months.&#xD;
&#xD;
        3. chronic ITP: for patients with ITP lasting more than one year ( blood journal 2009).&#xD;
&#xD;
             -  Although lymphocytopenia is a commonly reported feature of many chronic autoimmune&#xD;
                disorders, differential white cell counts at presentation have seldom been&#xD;
                evaluated as predictors for development of chronic ITP ( Deel MD et al 2013) (Ahmed&#xD;
                et al 2010)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>lymphocyte count in immune thrombocytopenic purpura</measure>
    <time_frame>15 minutes</time_frame>
    <description>intital lymphocyte counts predictive value in immune thrombocytopenic purpura by complete blood picture</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1</enrollment>
  <condition>Thrombocytopenic Purpura</condition>
  <arm_group>
    <arm_group_label>immune thrombocytopenic purpura</arm_group_label>
    <description>immune thrombocytopenic purpura an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number we used complete blood picture</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>complete blood picture</intervention_name>
    <description>complete blood picture</description>
    <arm_group_label>immune thrombocytopenic purpura</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        primary immune Thrombocytopenic Purpura&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed cases of primary ITP , adults and children.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cases of secondary ITP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Dolagy nabil naguib</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Purpura</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</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/NCT03244410
org study id: LCITP
nct id: NCT03244410
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
-  immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by
           increased platelet destruction and decreased platelet number (cooper N et al 2006)

        -  recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial
           autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic
           forms may represent two distinct immunopathological disorders ( cooper N et al 2006) (
           Gern Sheimer T 2009 )
Immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased
      platelet destruction and decreased platelet number ( Cooper N et all 2006) platelet surface
      membrane proteins become antigenic for unknown reasons, leading to stimulation of the immune
      system, auto antibodies production and platelet destruction ( Gasbarrini A et all 2000) It is
      associated with the production of auto antibodies directed against platelet glycoprotein
      complex 2b/3a and/or 1b/1x , resulting in accelerated destruction of platelets by the
      reticular endothelial system via the activity of Fcc receptor bearing phagocytic cells (
      Provan & Newland et al 2002) Recent studies have demonstrated that the pathogenesis of ITP
      envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that
      acute and chronic forms may represent two distinct immunopathological disorders ( Cooper N et
      al 2006) ( Gern Sheimer T 2009)

      There are many phases of the disease:

        1. Newly diagnosed ITP : for all cases at diagnosis.

        2. persistent ITP: for patients with ITP between 3 to 12 months.

        3. chronic ITP: for patients with ITP lasting more than one year ( blood journal 2009).

             -  Although lymphocytopenia is a commonly reported feature of many chronic autoimmune
                disorders, differential white cell counts at presentation have seldom been
                evaluated as predictors for development of chronic ITP ( Deel MD et al 2013) (Ahmed
                et al 2010)
observational model: Other
time perspective: Other
measure: lymphocyte count in immune thrombocytopenic purpura
time frame: 15 minutes
description: intital lymphocyte counts predictive value in immune thrombocytopenic purpura by complete blood picture
arm group label: immune thrombocytopenic purpura
description: immune thrombocytopenic purpura an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number we used complete blood picture
intervention type: Diagnostic Test
intervention name: complete blood picture
description: complete blood picture
arm group label: immune thrombocytopenic purpura
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Dolagy nabil naguib
investigator title: principle investigator
mesh term: Purpura
mesh term: Purpura, Thrombocytopenic
mesh term: Purpura, Thrombocytopenic, Idiopathic