<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/NCT04482777</url>
  </required_header>
  <id_info>
    <org_study_id>Cellular immunity in ITP</org_study_id>
    <nct_id>NCT04482777</nct_id>
  </id_info>
  <brief_title>IL37,Tlymphocytes,NK Cells in Pathogenesis of ITP</brief_title>
  <official_title>IL37,Tlymphocytes ,NK Cells in Pathogenesis of Immune Thrombocytopenia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      To evaluate the role of IL37 in pathogenesis of ITP and to study the relation between&#xD;
      IL37,Tlymphocytes,NK cells in ITP&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Idiopathic thrombocytopenia or immune thrombocytopenia (ITP) is a hematological condition&#xD;
      which is characterized by a low platelet count of less than 100 x 109L . Symptoms of ITP can&#xD;
      vary but tend to be symptoms of thrombocytopenia in general, such as petechiae, purpura,&#xD;
      mucosal bleeding and in the most severe cases fatal intracranial hemorrhage(1,2) Interleukin&#xD;
      (IL)-37, a novel anti-inflammatory cytokine previously known as interleukin-1 family member 7&#xD;
      before it was renamed, has a pivotal role in the suppression of immune responses (3,4). IL-37&#xD;
      is widely expressed in several types of cells, tissues and organs, including peripheral blood&#xD;
      mononuclear cells (PBMCs) (5). The major role of IL-37 is to decrease excessive inflammation&#xD;
      in innate and adaptive immune diseases, mainly by inhibiting the expression, production and&#xD;
      function of pro-inflammatory cytokines, including IL-1α, IL-6, tumor necrosis factor (TNF)&#xD;
      and macrophage inflammatory protein-2. The abundance of these cytokines has been reported to&#xD;
      increase with the silencing of endogenous IL-37 in human blood cells (3,6).Aberrant&#xD;
      expression of IL-37 has been observed in several inflammatory and autoimmune diseases&#xD;
      However, the role of IL-37 in ITP has remained elusive. Immune thrombocytopenia pathogenesis&#xD;
      is a complicated process. T cell immune abnormalities are involved in ITP pathogenesis. These&#xD;
      abnormalities include platelet auto-antigen reactive cytotoxic T cells, abnormal numbers and&#xD;
      functions of T regulatory cells, loss of Th1/Th2 balance, megakaryocyte maturation&#xD;
      abnormalities and abnormal T cell anergy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 30, 2023</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To decrease the immunity complications in ITP patients</measure>
    <time_frame>Baseline</time_frame>
    <description>Early detection of immunity complications in ITP patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To decrease case fatality rate</measure>
    <time_frame>Baseline</time_frame>
    <description>Early detection of immunity complication will decrease mortality rate</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>ITP</condition>
  <arm_group>
    <arm_group_label>ITP</arm_group_label>
    <description>Patient newly diagnosied with ITP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treated</arm_group_label>
    <description>Patients with ITP recived treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Healthy people</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteriod for treated patients</intervention_name>
    <description>Drug given to some patients with autoimmune disease</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>ITP</arm_group_label>
    <arm_group_label>Treated</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        To study initially enrolled 90 patients with ITP in Assiut hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with ITP (moderate and sever) different age group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with stroke and myocardial infarction,malignant tumors or pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Asmaa Mohamed</last_name>
    <phone>01027575354</phone>
    <email>mohamedasmaa550@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marwa Mohamed</last_name>
    <phone>01092288360</phone>
  </overall_contact_backup>
  <reference>
    <citation>Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835. doi: 10.1182/blood-2017-03-754119. Epub 2017 Apr 17.</citation>
    <PMID>28416506</PMID>
  </reference>
  <reference>
    <citation>Kistangari G, McCrae KR. Immune thrombocytopenia. Hematol Oncol Clin North Am. 2013 Jun;27(3):495-520. doi: 10.1016/j.hoc.2013.03.001.</citation>
    <PMID>23714309</PMID>
  </reference>
  <reference>
    <citation>Chen Z, Qu W, Wang HQ, Xing LM, Wu YH, Liu ZY, Zhang Y, Liu H, Dong XF, Tao JL, Shao ZH. [Relationship of Peripheral Blood IL-37 Expression with T Lymphocytes Subsets and NK Cells in Patients with Primary Immune Thrombocytopenia]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2019 Aug;27(4):1201-1207. doi: 10.19746/j.cnki.issn.1009-2137.2019.04.034. Chinese.</citation>
    <PMID>31418380</PMID>
  </reference>
  <reference>
    <citation>Zhao Y, Ni X, Xu P, Liu Q, Sun T, Liu X, Ji X, Qiu J, Li J, Wang S, Han P, Peng J, Hou M, Li G. Interleukin-37 reduces inflammation and impairs phagocytosis of platelets in immune thrombocytopenia (ITP). Cytokine. 2020 Jan;125:154853. doi: 10.1016/j.cyto.2019.154853. Epub 2019 Sep 23. Erratum In: Cytokine. 2022 Jul;155:155900.</citation>
    <PMID>31557634</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Asmaa Mohamed Elsayed</investigator_full_name>
    <investigator_title>Resident physician</investigator_title>
  </responsible_party>
  <!-- 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/NCT04482777
org study id: Cellular immunity in ITP
nct id: NCT04482777
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the role of IL37 in pathogenesis of ITP and to study the relation between
      IL37,Tlymphocytes,NK cells in ITP
Idiopathic thrombocytopenia or immune thrombocytopenia (ITP) is a hematological condition
      which is characterized by a low platelet count of less than 100 x 109L . Symptoms of ITP can
      vary but tend to be symptoms of thrombocytopenia in general, such as petechiae, purpura,
      mucosal bleeding and in the most severe cases fatal intracranial hemorrhage(1,2) Interleukin
      (IL)-37, a novel anti-inflammatory cytokine previously known as interleukin-1 family member 7
      before it was renamed, has a pivotal role in the suppression of immune responses (3,4). IL-37
      is widely expressed in several types of cells, tissues and organs, including peripheral blood
      mononuclear cells (PBMCs) (5). The major role of IL-37 is to decrease excessive inflammation
      in innate and adaptive immune diseases, mainly by inhibiting the expression, production and
      function of pro-inflammatory cytokines, including IL-1α, IL-6, tumor necrosis factor (TNF)
      and macrophage inflammatory protein-2. The abundance of these cytokines has been reported to
      increase with the silencing of endogenous IL-37 in human blood cells (3,6).Aberrant
      expression of IL-37 has been observed in several inflammatory and autoimmune diseases
      However, the role of IL-37 in ITP has remained elusive. Immune thrombocytopenia pathogenesis
      is a complicated process. T cell immune abnormalities are involved in ITP pathogenesis. These
      abnormalities include platelet auto-antigen reactive cytotoxic T cells, abnormal numbers and
      functions of T regulatory cells, loss of Th1/Th2 balance, megakaryocyte maturation
      abnormalities and abnormal T cell anergy.
observational model: Case-Control
time perspective: Retrospective
measure: To decrease the immunity complications in ITP patients
time frame: Baseline
description: Early detection of immunity complications in ITP patients
measure: To decrease case fatality rate
time frame: Baseline
description: Early detection of immunity complication will decrease mortality rate
arm group label: ITP
description: Patient newly diagnosied with ITP
arm group label: Treated
description: Patients with ITP recived treatment
arm group label: Control
description: Healthy people
intervention type: Drug
intervention name: Corticosteriod for treated patients
description: Drug given to some patients with autoimmune disease
arm group label: Control
arm group label: ITP
arm group label: Treated
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 60 Years
last name: Asmaa Mohamed
phone: 01027575354
email: mohamedasmaa550@yahoo.com
last name: Marwa Mohamed
phone: 01092288360
citation: Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835. doi: 10.1182/blood-2017-03-754119. Epub 2017 Apr 17.
PMID: 28416506
citation: Kistangari G, McCrae KR. Immune thrombocytopenia. Hematol Oncol Clin North Am. 2013 Jun;27(3):495-520. doi: 10.1016/j.hoc.2013.03.001.
PMID: 23714309
citation: Chen Z, Qu W, Wang HQ, Xing LM, Wu YH, Liu ZY, Zhang Y, Liu H, Dong XF, Tao JL, Shao ZH. [Relationship of Peripheral Blood IL-37 Expression with T Lymphocytes Subsets and NK Cells in Patients with Primary Immune Thrombocytopenia]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2019 Aug;27(4):1201-1207. doi: 10.19746/j.cnki.issn.1009-2137.2019.04.034. Chinese.
PMID: 31418380
citation: Zhao Y, Ni X, Xu P, Liu Q, Sun T, Liu X, Ji X, Qiu J, Li J, Wang S, Han P, Peng J, Hou M, Li G. Interleukin-37 reduces inflammation and impairs phagocytosis of platelets in immune thrombocytopenia (ITP). Cytokine. 2020 Jan;125:154853. doi: 10.1016/j.cyto.2019.154853. Epub 2019 Sep 23. Erratum In: Cytokine. 2022 Jul;155:155900.
PMID: 31557634
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Asmaa Mohamed Elsayed
investigator title: Resident physician