<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/NCT01668381</url>
  </required_header>
  <id_info>
    <org_study_id>2010B031600209</org_study_id>
    <nct_id>NCT01668381</nct_id>
  </id_info>
  <brief_title>Enumeration and Function Analysis of Treg Cells in Peripheral Blood of HCC Patients Before and After Ablation Therapy</brief_title>
  <official_title>Enumeration and Function Analysis of Treg Cells in Peripheral Blood of HCC Patients Before and After Ablation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangdong Province, Department of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the enumeration and function changes of regulatory&#xD;
      t cells in peripheral blood of hepatocellular carcinoma patients before and 1 week, 4 weeks&#xD;
      after ablation therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regulatory T cells，which are also called Treg cells，play an important role in suppressing&#xD;
      anti-tumor immunity.Accumulated evidences indicate that Treg cells are elevated in peripheral&#xD;
      blood,however,there are also reports that decreased Treg cells are found in hepatocellular&#xD;
      patients.This study focuses on the changes of Treg cells ratio in peripheral blood of&#xD;
      hepatocellular carcinoma patients before and 1 week, 4 weeks after ablation ,also its&#xD;
      functional cytokines,such as TGF-β,IL-10,IFN-γ,and inhibition function when co-cultured with&#xD;
      CD4+CD25-、CD8+ cells. The investigators speculate that a decreased Treg ratio will be found&#xD;
      in patients who receive ablation therapy,and its function cytokines,moreover,CD4+CD25-、CD8+&#xD;
      cells' proliferation and function could be inhibited when co-cultured with Treg cells.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2013</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>variation of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy</measure>
    <time_frame>4 weeks post therapy</time_frame>
    <description>changes of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,such as CD3+,CD4+,CD8+,CD4+CD25+FOXP3+(Treg) cells.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>variation of serum IL-10,TGF-β1,IFN-γ concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy</measure>
    <time_frame>4 weeks post therapy</time_frame>
    <description>variation of serum IL-10,TGF-β1,IFN-γ concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>variation of proliferation suppression ability of CD4+CD25+ T cells of HCC patients before and 1,4 weeks after radiofrequency ablation therapy</measure>
    <time_frame>4 weeks post therapy</time_frame>
    <description>CD4+CD25+ T cells, derived from peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,were co-cultured with CD4+CD25- or CD8+ T cells,which were stimulated by CD3/CD28 MACSiBead Particles.CD4+CD25- and CD8+ T cells proliferation changes were analysed to test CD4+CD25+ T cell suppression ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>variation of suppression ability of CD4+CD25+ T cells of HCC patients on cytokine secretion before and 1,4 weeks after radiofrequency ablation therapy</measure>
    <time_frame>4 weeks post therapy</time_frame>
    <description>CD4+CD25+ T cells, derived from peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,were co-cultured with CD4+CD25- or CD8+ T cells,which were stimulated by CD3/CD28 MACSiBead Particles.supernatant IFN-γ were analysed to test CD4+CD25+ T cell suppression ability.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>HCC patients</arm_group_label>
    <description>Hepatocellular carcinoma patients treated by radiofrequency ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>radiofrequency ablation</intervention_name>
    <description>the patients are prepared by local anesthesia and intravenous sedative.guided by the ultrasound,the antenna used for radiofrequency ablation ablation is placed in the tumor to destroy tumor tissues,the output power and duration are depended by the tumor volume and location.</description>
    <arm_group_label>HCC patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        hepatocellular carcinoma patients underwent radiofrequency ablation therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a&#xD;
             diagnosis of hepatocellular carcinoma and alphafetoprotein&gt;400μg/L；or two or more&#xD;
             dynamic imagine with a diagnosis of hepatocellular carcinoma&#xD;
&#xD;
          -  Child-Pugh A or B&#xD;
&#xD;
          -  well preserved renal and hematopoietic Function&#xD;
&#xD;
          -  receive ablation therapy through percutaneous radiofrequency ablation or microwave&#xD;
             ablation or ethanol injection ablation or any kind of combination of them.&#xD;
&#xD;
          -  achieve complete ablation accessed by contrast-enhanced CT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  incomplete ablation&#xD;
&#xD;
          -  remote metastasis&#xD;
&#xD;
          -  Child-Pugh C&#xD;
&#xD;
          -  general infection&#xD;
&#xD;
          -  autoimmune diseases&#xD;
&#xD;
          -  suffer from other tumors concurrently or in last five years&#xD;
&#xD;
          -  patients with immune deficit or infected by HIV&#xD;
&#xD;
          -  receiving glucocorticoid or other medicine inhibiting immune system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Kuang, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>First Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qing-qi Ren, Bachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sun Yat-Sen University,First Affiliated Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>March 18, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>February 20, 2013</last_update_submitted>
  <last_update_submitted_qc>February 20, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 21, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Ming Kuang,MD,PhD</investigator_full_name>
    <investigator_title>MD,PhD</investigator_title>
  </responsible_party>
  <keyword>hepatocellular carcinoma</keyword>
  <keyword>Catheter Ablation</keyword>
  <keyword>T-Lymphocytes, Regulatory</keyword>
  <keyword>IL-10</keyword>
  <keyword>TGF-β</keyword>
  <keyword>IFN-γ</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</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/NCT01668381
org study id: 2010B031600209
nct id: NCT01668381
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the enumeration and function changes of regulatory
      t cells in peripheral blood of hepatocellular carcinoma patients before and 1 week, 4 weeks
      after ablation therapy.
Regulatory T cells，which are also called Treg cells，play an important role in suppressing
      anti-tumor immunity.Accumulated evidences indicate that Treg cells are elevated in peripheral
      blood,however,there are also reports that decreased Treg cells are found in hepatocellular
      patients.This study focuses on the changes of Treg cells ratio in peripheral blood of
      hepatocellular carcinoma patients before and 1 week, 4 weeks after ablation ,also its
      functional cytokines,such as TGF-β,IL-10,IFN-γ,and inhibition function when co-cultured with
      CD4+CD25-、CD8+ cells. The investigators speculate that a decreased Treg ratio will be found
      in patients who receive ablation therapy,and its function cytokines,moreover,CD4+CD25-、CD8+
      cells' proliferation and function could be inhibited when co-cultured with Treg cells.
observational model: Case-Only
time perspective: Prospective
measure: variation of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy
time frame: 4 weeks post therapy
description: changes of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,such as CD3+,CD4+,CD8+,CD4+CD25+FOXP3+(Treg) cells.
measure: variation of serum IL-10,TGF-β1,IFN-γ concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy
time frame: 4 weeks post therapy
description: variation of serum IL-10,TGF-β1,IFN-γ concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy
measure: variation of proliferation suppression ability of CD4+CD25+ T cells of HCC patients before and 1,4 weeks after radiofrequency ablation therapy
time frame: 4 weeks post therapy
description: CD4+CD25+ T cells, derived from peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,were co-cultured with CD4+CD25- or CD8+ T cells,which were stimulated by CD3/CD28 MACSiBead Particles.CD4+CD25- and CD8+ T cells proliferation changes were analysed to test CD4+CD25+ T cell suppression ability.
measure: variation of suppression ability of CD4+CD25+ T cells of HCC patients on cytokine secretion before and 1,4 weeks after radiofrequency ablation therapy
time frame: 4 weeks post therapy
description: CD4+CD25+ T cells, derived from peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,were co-cultured with CD4+CD25- or CD8+ T cells,which were stimulated by CD3/CD28 MACSiBead Particles.supernatant IFN-γ were analysed to test CD4+CD25+ T cell suppression ability.
arm group label: HCC patients
description: Hepatocellular carcinoma patients treated by radiofrequency ablation
intervention type: Procedure
intervention name: radiofrequency ablation
description: the patients are prepared by local anesthesia and intravenous sedative.guided by the ultrasound,the antenna used for radiofrequency ablation ablation is placed in the tumor to destroy tumor tissues,the output power and duration are depended by the tumor volume and location.
arm group label: HCC patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ming Kuang, MD,PhD
role: Study Chair
affiliation: First Affiliated Hospital, Sun Yat-Sen University
last name: Qing-qi Ren, Bachelor
role: Principal Investigator
affiliation: First Affiliated Hospital, Sun Yat-Sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
investigator full name: Ming Kuang,MD,PhD
investigator title: MD,PhD
mesh term: Carcinoma, Hepatocellular