<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/NCT03027089</url>
  </required_header>
  <id_info>
    <org_study_id>hr4987</org_study_id>
    <nct_id>NCT03027089</nct_id>
  </id_info>
  <brief_title>Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA)-Multicenter Study</brief_title>
  <official_title>Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA) in Chinese Patients -Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Navy General Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Air Force General Hospital of the PLA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>307 Hospital of PLA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      chronic pulmonary aspergillosis (CPA) is one of the most refractory pulmonary infectious&#xD;
      diseases, and the incidence is increased rapidly in recent years. Serum detection of&#xD;
      Aspergillus-specific IgG is considered to be the most reliable method for diagnosing CPA,&#xD;
      however, there is no formal report on the appropriate cut-off value for Aspergillus-specific&#xD;
      IgG assay in Chinese patients. This study aimed to establish the datum.&#xD;
&#xD;
      Besides aspergillus-specific IgG, there are two other specific antibodies IgM and IgA. IgM is&#xD;
      associated with the acute phase of an infection and IgA is associated with mucosal immunity.&#xD;
      Their diagnostic values in CPA are still not clear. Meanwhile, whether detection of antibody&#xD;
      levels in bronchoalveolar lavage fluid (BALF) could be useful in diagnosis of CPA has not&#xD;
      been investigated. In this study, the serum and BALF levels of IgG, IgM and IgA would be&#xD;
      detected simultaneously by the commercial available kits.&#xD;
&#xD;
      The investigators will establish the cut-off values of three antibodies by proven CPA&#xD;
      patients and negative controls. Then, the cut-off values will be assessed in participants who&#xD;
      have a suspected CPA, and the sensitivity, specificity, positive and negative predict value&#xD;
      of the antibodies assays will be compared with that of standard diagnostic methods.&#xD;
&#xD;
      After performing the above diagnostic tests, CPA could be diagnosed more accurately and&#xD;
      rapidly, so that the antifungal therapy could be evaluated more correctly and timely.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The levels of Aspergillus-specific IgG, IgM and IgA in sera and BALF from 560 patients with suspected CPA and 100 healthy blood donors were tested by ELISA assays</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">560</enrollment>
  <condition>Chronic Pulmonary Aspergillosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects were selected with lesions presented as cavity, nodule，mass or &quot;destroyed&#xD;
        lung&quot; caused by fibrosis in CT imaging&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        18 years to 85 years Lesions presented as cavity, nodule，mass or &quot;destroyed lung&quot; caused by&#xD;
        fibrosis in CT imaging&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  seriously immunocompromised patients&#xD;
&#xD;
               1. Recent history of neutropenia (&lt;0.5 × 109neutrophils/L [&lt;500 neutrophils/mm3]&#xD;
                  for&gt;10 days) temporally related to the onset of fungal disease&#xD;
&#xD;
               2. Receipt of an allogeneic stem cell transplant&#xD;
&#xD;
               3. Prolonged use of corticosteroids (excluding among patients with allergic&#xD;
                  bronchopulmonary aspergillosis) at a mean minimum dose of 0.3 mg/kg/day of&#xD;
                  prednisone equivalent for &gt;3 weeks&#xD;
&#xD;
               4. Treatment with other recognized T cell immunosuppressants, such as cyclosporine,&#xD;
                  TNF-a blockers, specific monoclonal antibodies (such as alemtuzumab), or&#xD;
                  nucleoside analogues during the past 90 days&#xD;
&#xD;
               5. Inherited severe immunodeficiency (such as chronic granulomatous disease or&#xD;
                  severe combined immunodeficiency)&#xD;
&#xD;
          -  antifungal drug use within 3 months of screening&#xD;
&#xD;
          -  dropout&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  no inform consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>xiuqing ma, Doctor</last_name>
    <phone>+8601066936184</phone>
    <email>mxq820812@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>301 PLA general hospital</name>
      <address>
        <city>BeiJing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xiuqing ma, Doctor</last_name>
      <phone>+8601066936184</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Denning DW, Cadranel J, Beigelman-Aubry C, Ader F, Chakrabarti A, Blot S, Ullmann AJ, Dimopoulos G, Lange C; European Society for Clinical Microbiology and Infectious Diseases and European Respiratory Society. Chronic pulmonary aspergillosis: rationale and clinical guidelines for diagnosis and management. Eur Respir J. 2016 Jan;47(1):45-68. doi: 10.1183/13993003.00583-2015.</citation>
    <PMID>26699723</PMID>
  </results_reference>
  <results_reference>
    <citation>Page ID, Richardson MD, Denning DW. Comparison of six Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA). J Infect. 2016 Feb;72(2):240-9. doi: 10.1016/j.jinf.2015.11.003. Epub 2015 Dec 8.</citation>
    <PMID>26680697</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Lixin Xie</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Aspergillus-specific IgG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspergillosis</mesh_term>
    <mesh_term>Pulmonary Aspergillosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03027089
org study id: hr4987
nct id: NCT03027089
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA)
chronic pulmonary aspergillosis (CPA) is one of the most refractory pulmonary infectious
      diseases, and the incidence is increased rapidly in recent years. Serum detection of
      Aspergillus-specific IgG is considered to be the most reliable method for diagnosing CPA,
      however, there is no formal report on the appropriate cut-off value for Aspergillus-specific
      IgG assay in Chinese patients. This study aimed to establish the datum.

      Besides aspergillus-specific IgG, there are two other specific antibodies IgM and IgA. IgM is
      associated with the acute phase of an infection and IgA is associated with mucosal immunity.
      Their diagnostic values in CPA are still not clear. Meanwhile, whether detection of antibody
      levels in bronchoalveolar lavage fluid (BALF) could be useful in diagnosis of CPA has not
      been investigated. In this study, the serum and BALF levels of IgG, IgM and IgA would be
      detected simultaneously by the commercial available kits.

      The investigators will establish the cut-off values of three antibodies by proven CPA
      patients and negative controls. Then, the cut-off values will be assessed in participants who
      have a suspected CPA, and the sensitivity, specificity, positive and negative predict value
      of the antibodies assays will be compared with that of standard diagnostic methods.

      After performing the above diagnostic tests, CPA could be diagnosed more accurately and
      rapidly, so that the antifungal therapy could be evaluated more correctly and timely.
observational model: Cohort
time perspective: Prospective
measure: The levels of Aspergillus-specific IgG, IgM and IgA in sera and BALF from 560 patients with suspected CPA and 100 healthy blood donors were tested by ELISA assays
time frame: 2 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: xiuqing ma, Doctor
phone: +8601066936184
email: mxq820812@163.com
facility: 
status: Recruiting
contact: 
country: China
citation: Denning DW, Cadranel J, Beigelman-Aubry C, Ader F, Chakrabarti A, Blot S, Ullmann AJ, Dimopoulos G, Lange C; European Society for Clinical Microbiology and Infectious Diseases and European Respiratory Society. Chronic pulmonary aspergillosis: rationale and clinical guidelines for diagnosis and management. Eur Respir J. 2016 Jan;47(1):45-68. doi: 10.1183/13993003.00583-2015.
PMID: 26699723
citation: Page ID, Richardson MD, Denning DW. Comparison of six Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA). J Infect. 2016 Feb;72(2):240-9. doi: 10.1016/j.jinf.2015.11.003. Epub 2015 Dec 8.
PMID: 26680697
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Lixin Xie
investigator title: professor
mesh term: Aspergillosis
mesh term: Pulmonary Aspergillosis
sharing ipd: No