<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/NCT01731262</url>
  </required_header>
  <id_info>
    <org_study_id>中大附三医伦[2012]2-75号</org_study_id>
    <nct_id>NCT01731262</nct_id>
  </id_info>
  <brief_title>Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis</brief_title>
  <official_title>Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Third Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Natural Science Foundation of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Third Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rheumatoid arthritis(RA) with a high incidence and high morbidity, the pathogenesis has not&#xD;
      been fully elucidated. Fibroblast-like synovial cells excessive proliferation and synovial&#xD;
      angiogenesis is the most important cause of RA synovitis and joint destruction. Our study was&#xD;
      to find the role of Sonic Hedgehog(SHH) pathway in regulating proliferation of&#xD;
      fibroblast-like synovial cells and modulating excess angiogenesis of synovial tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      4ml blood from active RA patients(n=35) and healthy volunteers (n=35) will be collected&#xD;
&#xD;
        -  peripheral blood mononuclear cells will be detached&#xD;
&#xD;
        -  messenger ribonucleic acid expression of Sonic Hedgehog pathway associated factors in&#xD;
           both groups will be detected&#xD;
&#xD;
      Synovial tissues from 4 RA patients and 4 patients with traumatic or meniscal injury who need&#xD;
      to carry out knee joint replacement operation will be collected&#xD;
&#xD;
        -  inflammatory feature of synovial tissue will be observed&#xD;
&#xD;
        -  the expression of Shh, Ptch1, Gli1 and Smo in synovial tissue will be detected by&#xD;
           immunohistochemistry assay&#xD;
&#xD;
        -  fibroblast-like synoviocytes will be cultured from synovial tissue of RA patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">January 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>mRNA expression</measure>
    <time_frame>1 day (December 15, 2012)</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">78</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <condition>Neovascularization, Pathologic</condition>
  <condition>Synovitis</condition>
  <arm_group>
    <arm_group_label>RA group</arm_group_label>
    <description>expression of Shh pathway associated factors from peripheral blood mononuclear cells or synovial tissues will be detected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>expression of Shh pathway associated factors from peripheral blood mononuclear cells or synovial tissues will be detected</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        residents of south China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  definitely diagnosed&#xD;
&#xD;
          -  the disease is active (DAS28&gt;3.2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  combined with severe organ dysfunction&#xD;
&#xD;
          -  combined with other rheumatic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianlin Huang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Third Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianlin Huang, PhD</last_name>
    <phone>86 02085252194</phone>
    <email>jianlin_h@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Guihua Chen, PhD</last_name>
    <phone>86 02085252205</phone>
    <email>zssyyuanzhangban@163.com</email>
  </overall_contact_backup>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 20, 2012</last_update_submitted>
  <last_update_submitted_qc>November 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Third Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Shangling Zhu</investigator_full_name>
    <investigator_title>Post-Graduate</investigator_title>
  </responsible_party>
  <keyword>Arthritis, Rheumatoid</keyword>
  <keyword>Sonic hedgehog protein, human</keyword>
  <keyword>Neovascularization, Pathologic</keyword>
  <keyword>Synovitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Synovitis</mesh_term>
    <mesh_term>Neovascularization, Pathologic</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/NCT01731262
org study id: 中大附三医伦[2012]2-75号
nct id: NCT01731262
lead sponsor: 
collaborator: 
has dmc: Yes
Rheumatoid arthritis(RA) with a high incidence and high morbidity, the pathogenesis has not
      been fully elucidated. Fibroblast-like synovial cells excessive proliferation and synovial
      angiogenesis is the most important cause of RA synovitis and joint destruction. Our study was
      to find the role of Sonic Hedgehog(SHH) pathway in regulating proliferation of
      fibroblast-like synovial cells and modulating excess angiogenesis of synovial tissue.
4ml blood from active RA patients(n=35) and healthy volunteers (n=35) will be collected

        -  peripheral blood mononuclear cells will be detached

        -  messenger ribonucleic acid expression of Sonic Hedgehog pathway associated factors in
           both groups will be detected

      Synovial tissues from 4 RA patients and 4 patients with traumatic or meniscal injury who need
      to carry out knee joint replacement operation will be collected

        -  inflammatory feature of synovial tissue will be observed

        -  the expression of Shh, Ptch1, Gli1 and Smo in synovial tissue will be detected by
           immunohistochemistry assay

        -  fibroblast-like synoviocytes will be cultured from synovial tissue of RA patients
observational model: Case-Control
measure: mRNA expression
time frame: 1 day (December 15, 2012)
arm group label: RA group
description: expression of Shh pathway associated factors from peripheral blood mononuclear cells or synovial tissues will be detected
arm group label: control group
description: expression of Shh pathway associated factors from peripheral blood mononuclear cells or synovial tissues will be detected
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jianlin Huang, PhD
role: Principal Investigator
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
last name: Jianlin Huang, PhD
phone: 86 02085252194
email: jianlin_h@163.com
last name: Guihua Chen, PhD
phone: 86 02085252205
email: zssyyuanzhangban@163.com
responsible party type: Principal Investigator
investigator affiliation: Third Affiliated Hospital, Sun Yat-Sen University
investigator full name: Shangling Zhu
investigator title: Post-Graduate
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Synovitis
mesh term: Neovascularization, Pathologic