<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/NCT01685099</url>
  </required_header>
  <id_info>
    <org_study_id>201207061RIC</org_study_id>
    <nct_id>NCT01685099</nct_id>
  </id_info>
  <brief_title>Evaluating the Diagnostic Validity of Inflammation-associated Markers for Tuberculous Pleurisy</brief_title>
  <official_title>Evaluating the Diagnostic Validity of Inflammation-associated Markers for Tuberculous Pleurisy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To investigate the difference of PE inflammation/apoptosis-associated markers between TB&#xD;
           pleurisy and non-TB pleurisy&#xD;
&#xD;
        2. To investigate the difference of neutrophil apoptosis in exudative PE between TB&#xD;
           pleurisy and non-TB pleurisy&#xD;
&#xD;
        3. To investigate the change of apoptosis pattern of PE neutrophil, before and after TB&#xD;
           antigen stimulation, and compare the difference between TB pleurisy and non-TB pleurisy&#xD;
&#xD;
        4. To investigate diagnostic aid of the inflammation/apoptosis-associated markers and&#xD;
           apoptosis pattern of PE neutrophil for tuberculous pleurisy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tuberculosis (TB) remains a global health problem even though it has nearly been eradicated&#xD;
      in some developed countries. Because of variable manifestations and the difficulty in&#xD;
      collecting clinical samples, extra-pulmonary TB is usually difficult to early diagnose.&#xD;
      Tuberculous pleurisy (TP) is one of the most common extra-pulmonary infection and accounts&#xD;
      for approximately 5% of all forms of TB. The gold standard for diagnosing TP is mycobacterial&#xD;
      culture of pleural effusion (PE), pleura tissue, which requires weeks to yield. The treatment&#xD;
      could thus be delayed, resulting in an increased mortality rate. In addition, mycobacterial&#xD;
      culture is not so sensitive for PE and with positivity in less than two thirds of cases with&#xD;
      TB pleurisy.&#xD;
&#xD;
      For diagnosing TP, PE biomarkers are required to be investigated in addition to traditional&#xD;
      PE cell counting and biochemistry. In particularly, inflammation-associated cytokines and&#xD;
      apoptosis-associated markers may be important because the two pathways involve in TB&#xD;
      infection/defense mechanism. For inflammation-association markers, current literature is not&#xD;
      comprehensive except IFN-gamma and IFN-gamma release assay (IGRA). However, the result of&#xD;
      IGRA using PE is disappointed. We should study other PE inflammation markers such as&#xD;
      IFN-induced protein-10, interleukin [IL]-2, IL-12 and so on. On the other hand, apoptosis&#xD;
      suppression is one of escape mechanisms in TB pathogenesis. Macrophage, dendritic cell, and&#xD;
      neutrophil are reportedly inhibited for apoptosis in TB infection. But the apoptosis of PE&#xD;
      neutrophil are rarely studied. Moreover, the role of apoptosis-associated markers (Fas ligand&#xD;
      [FasL], decoy receptor 3, lipoxin, prostaglandin E2, caspases) in PE has rarely been&#xD;
      investigated in diagnosing TP except FasL. Therefore, we conduct a prospective study to&#xD;
      investigate inflammation/apoptosis-associated markers in exudative PE and apoptosis of PE&#xD;
      neutrophil to analyze their diagnostic usefulness for TP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_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>diagnosis of tuberculous pleurisy</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>To Investigate Diagnostic Aid of the Inflammation and Apoptosis-associated Markers and Apoptosis Pattern of PE Neutrophil for Tuberculous Pleurisy</condition>
  <arm_group>
    <arm_group_label>Group with tuberculous pleurisy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Group with non-tuberculous pleurisy</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      pleural effusion&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1. Patients with tuberculous pleural effusion&#xD;
&#xD;
          2. Patients with pleural effusion due to causes other than tuberculosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient older than 20 years old&#xD;
&#xD;
          -  patients with exudative pleural effusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chin-Chung Shu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chin-Chung Shu, MD</last_name>
    <phone>886-972653087</phone>
    <email>ccshu139@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chin-Chung Shu, MD</last_name>
      <phone>886972653087</phone>
      <email>ccshu139@ntu.edu.tw</email>
    </contact>
    <investigator>
      <last_name>Chin-Chung Shu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 11, 2012</last_update_submitted>
  <last_update_submitted_qc>September 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diagnosis, inflammation-associated markers, pleural effusion, tuberculosis, tuberculous pleurisy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Pleurisy</mesh_term>
    <mesh_term>Tuberculosis, Pleural</mesh_term>
    <mesh_term>Inflammation</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/NCT01685099
org study id: 201207061RIC
nct id: NCT01685099
lead sponsor: 
has dmc: No
1. To investigate the difference of PE inflammation/apoptosis-associated markers between TB
           pleurisy and non-TB pleurisy

        2. To investigate the difference of neutrophil apoptosis in exudative PE between TB
           pleurisy and non-TB pleurisy

        3. To investigate the change of apoptosis pattern of PE neutrophil, before and after TB
           antigen stimulation, and compare the difference between TB pleurisy and non-TB pleurisy

        4. To investigate diagnostic aid of the inflammation/apoptosis-associated markers and
           apoptosis pattern of PE neutrophil for tuberculous pleurisy
Tuberculosis (TB) remains a global health problem even though it has nearly been eradicated
      in some developed countries. Because of variable manifestations and the difficulty in
      collecting clinical samples, extra-pulmonary TB is usually difficult to early diagnose.
      Tuberculous pleurisy (TP) is one of the most common extra-pulmonary infection and accounts
      for approximately 5% of all forms of TB. The gold standard for diagnosing TP is mycobacterial
      culture of pleural effusion (PE), pleura tissue, which requires weeks to yield. The treatment
      could thus be delayed, resulting in an increased mortality rate. In addition, mycobacterial
      culture is not so sensitive for PE and with positivity in less than two thirds of cases with
      TB pleurisy.

      For diagnosing TP, PE biomarkers are required to be investigated in addition to traditional
      PE cell counting and biochemistry. In particularly, inflammation-associated cytokines and
      apoptosis-associated markers may be important because the two pathways involve in TB
      infection/defense mechanism. For inflammation-association markers, current literature is not
      comprehensive except IFN-gamma and IFN-gamma release assay (IGRA). However, the result of
      IGRA using PE is disappointed. We should study other PE inflammation markers such as
      IFN-induced protein-10, interleukin [IL]-2, IL-12 and so on. On the other hand, apoptosis
      suppression is one of escape mechanisms in TB pathogenesis. Macrophage, dendritic cell, and
      neutrophil are reportedly inhibited for apoptosis in TB infection. But the apoptosis of PE
      neutrophil are rarely studied. Moreover, the role of apoptosis-associated markers (Fas ligand
      [FasL], decoy receptor 3, lipoxin, prostaglandin E2, caspases) in PE has rarely been
      investigated in diagnosing TP except FasL. Therefore, we conduct a prospective study to
      investigate inflammation/apoptosis-associated markers in exudative PE and apoptosis of PE
      neutrophil to analyze their diagnostic usefulness for TP.
observational model: Case-Control
time perspective: Prospective
measure: diagnosis of tuberculous pleurisy
time frame: 2 years
measure: mortality
time frame: 2 years
arm group label: Group with tuberculous pleurisy
arm group label: Group with non-tuberculous pleurisy
pleural effusion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chin-Chung Shu, MD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Chin-Chung Shu, MD
phone: 886-972653087
email: ccshu139@ntu.edu.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Pleurisy
mesh term: Tuberculosis, Pleural
mesh term: Inflammation