<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/NCT02202655</url>
  </required_header>
  <id_info>
    <org_study_id>13501185982</org_study_id>
    <nct_id>NCT02202655</nct_id>
  </id_info>
  <brief_title>Study of Changes of Lymphocyte Subsets in Chemotherapy Course of Patients With Non-small Cell Lung Cancer</brief_title>
  <acronym>NSCLC</acronym>
  <official_title>Study of Changes of Lymphocyte Subsets in Chemotherapy Course of Patients With Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Chao Yang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy&#xD;
      course of patients with non-small cell lung cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      patients with primary non-small cell lung cancer who received first chemotherapy in Beijing&#xD;
      Chaoyang Hospital affiliated to Capital Medical University were collected, and the percentage&#xD;
      of lymphocyte subsets at 9 time points before, during, and after chemotherapy was detected by&#xD;
      flow cytometry method.We will investigate the changes of patients' lymphocyte subsets in&#xD;
      chemotherapy courses. The correlation of the percentage of lymphocyte subsets and age,&#xD;
      gender, pathological type, clinical stage, surgery or not, clinical efficacy assessment will&#xD;
      be further analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the changes of patients' lymphocyte subsets in chemotherapy courses.</measure>
    <time_frame>up to cycle 4 day 9</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with non-small cell lung cancer who accept chemotherapy for the first time are&#xD;
        acceptable.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Each Period Non-small Cell Lung Cancer, Which Was Confirmed by Histopathology.&#xD;
             patients has only lung cancer .&#xD;
&#xD;
          -  Functional Status Score (PS) ≧ 70.&#xD;
&#xD;
          -  The first time for chemotherapy .&#xD;
&#xD;
          -  A Written Informed Consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Merging other tumors.&#xD;
&#xD;
          -  HAve autoimmune diseases.&#xD;
&#xD;
          -  AIDS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yingmin ma</last_name>
    <role>Study Director</role>
    <affiliation>Vice President of the Beijing chaoyang hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>qian wang, master</last_name>
    <phone>18810252602</phone>
    <email>wenqian.3334444@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>WangQian</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>qian wang, master</last_name>
      <phone>18810252602</phone>
      <email>wenqian.3334444@163.com</email>
    </contact>
    <investigator>
      <last_name>yingmin ma, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 28, 2014</last_update_submitted>
  <last_update_submitted_qc>July 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Chao Yang Hospital</investigator_affiliation>
    <investigator_full_name>Yingmin Ma</investigator_full_name>
    <investigator_title>Vice President of the Beijing chaoyang hospital</investigator_title>
  </responsible_party>
  <keyword>non- small cell lung cancer;</keyword>
  <keyword>lymphocyte subsets</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT02202655
org study id: 13501185982
nct id: NCT02202655
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy
      course of patients with non-small cell lung cancer
patients with primary non-small cell lung cancer who received first chemotherapy in Beijing
      Chaoyang Hospital affiliated to Capital Medical University were collected, and the percentage
      of lymphocyte subsets at 9 time points before, during, and after chemotherapy was detected by
      flow cytometry method.We will investigate the changes of patients' lymphocyte subsets in
      chemotherapy courses. The correlation of the percentage of lymphocyte subsets and age,
      gender, pathological type, clinical stage, surgery or not, clinical efficacy assessment will
      be further analyzed.
observational model: Case-Only
time perspective: Prospective
measure: the changes of patients' lymphocyte subsets in chemotherapy courses.
time frame: up to cycle 4 day 9
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: yingmin ma
role: Study Director
affiliation: Vice President of the Beijing chaoyang hospital
last name: qian wang, master
phone: 18810252602
email: wenqian.3334444@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Chao Yang Hospital
investigator full name: Yingmin Ma
investigator title: Vice President of the Beijing chaoyang hospital
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung