<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/NCT01680055</url>
  </required_header>
  <id_info>
    <org_study_id>Aplastic Anemia 1</org_study_id>
    <nct_id>NCT01680055</nct_id>
  </id_info>
  <brief_title>Collection of Blood and Bone Marrow From Patients With Aplastic Anemia for Analysis of Adhesion Molecules, Chemokines and Their Receptors</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</source>
  <brief_summary>
    <textblock>
      This study is designed to collect bone marrow and/or peripheral blood cells and plasma, for&#xD;
      the analysis of adhesion molecules, chemokines and their receptors from newly-diagnosed&#xD;
      aplastic anemia patients, and patients treated with antithymocyte globulin plus cyclosporine&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No eligible patient was enrolled.&#xD;
  </why_stopped>
  <start_date>February 2009</start_date>
  <completion_date type="Anticipated">November 2012</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>hematologic response</measure>
    <time_frame>6 months following antithymocyte globulin plus cyclosporine treatment</time_frame>
    <description>hematologic response at 6 months following antithymocyte globulin plus cyclosporine treatment, defined as no longer meeting the criteria for severe aplastic anemia</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Aplastic Anemia</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>AA-ATG</arm_group_label>
    <description>Acquired Aplastic Anemia Patients Treated with Antithymocyte Globulin plus Cyclosporine</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients With Aplastic Anemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who fulfilled entry criteria of acquired aplastic anemia age range 16-70&#xD;
             years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients complicated with diabetes, tumor, pregnancy, active infection, or connective&#xD;
             tissue diseases, such as systemic lupus erythematosus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>April 18, 2016</last_update_submitted>
  <last_update_submitted_qc>April 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Ming Hou</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Aplastic</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/NCT01680055
org study id: Aplastic Anemia 1
nct id: NCT01680055
lead sponsor: 
This study is designed to collect bone marrow and/or peripheral blood cells and plasma, for
      the analysis of adhesion molecules, chemokines and their receptors from newly-diagnosed
      aplastic anemia patients, and patients treated with antithymocyte globulin plus cyclosporine
observational model: Case-Control
time perspective: Prospective
measure: hematologic response
time frame: 6 months following antithymocyte globulin plus cyclosporine treatment
description: hematologic response at 6 months following antithymocyte globulin plus cyclosporine treatment, defined as no longer meeting the criteria for severe aplastic anemia
arm group label: AA-ATG
description: Acquired Aplastic Anemia Patients Treated with Antithymocyte Globulin plus Cyclosporine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Ming Hou
investigator title: Director
mesh term: Anemia
mesh term: Anemia, Aplastic