<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/NCT03260088</url>
  </required_header>
  <id_info>
    <org_study_id>PLEFF</org_study_id>
    <nct_id>NCT03260088</nct_id>
  </id_info>
  <brief_title>Evaluation Of Pleural Effusion At Assiut University Hospital</brief_title>
  <official_title>Evaluation Of Pleural Effusion At Assiut University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pleural effusion is an accumulation of fluid between the tissue layers that line the lungs&#xD;
      and chest cavity. It has an estimated prevalence of 320 per 100,000 people in industrialized&#xD;
      countries. The cause of the pleural effusion remains unclear in a substantial percentage of&#xD;
      patients with persistently exudative effusions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      They are classified broadly into exudative and transudative effusion based on Light's&#xD;
      criteria.&#xD;
&#xD;
      Several methods have been proposed for the identification of pleural effusion etiology&#xD;
      including pleural fluid cytology, pleural biopsy, thoracoscopy and computerized tomography.&#xD;
      However, these technologies have their own limitations.&#xD;
&#xD;
      The diagnosis of malignant pleural effusion is a vexing problem, since pleural fluid cytology&#xD;
      findings are positive in only 60% of cases on average. Tumor marker carcinoembryonic antigen&#xD;
      (CEA) can be positive in 80% of cases.&#xD;
&#xD;
      Thoracoscopy will establish the diagnosis in approximately 95% of cases, but this&#xD;
      interventional procedure may not be available at all facilities.&#xD;
&#xD;
      A new approach is needed to detect the cause of undiagnosed pleural effusions. Diagnosis of&#xD;
      idiopathic pleural effusion was made after a minimum of one year follow up with detailed&#xD;
      exploration including computed tomographic scanning to exclude other causes of effusion such&#xD;
      as malignant pleural effusion.&#xD;
&#xD;
      Because immunoglobulin G4 (IgG4)-related disease is recognized as a fibroinflammatory&#xD;
      condition of unknown cause that can affect multiple organs including the lungs and pleura,&#xD;
      IgG4 might be related to certain idiopathic pleural effusions.&#xD;
&#xD;
      The criteria of Common radiological findings of IgG4-related lung disease include hilar and&#xD;
      mediastinal lymphadenopathy, thickening of perilymphatic interstitium with or without&#xD;
      subpleural and/or peribronchovascular consolidation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 30, 2017</start_date>
  <completion_date type="Anticipated">January 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2019</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>diagnosis new causes of previously remained undiagnosed cases of pleural effusion by using IgG4 in Assiut university hospital</measure>
    <time_frame>one year</time_frame>
    <description>Immunoglobulin G4 will be puified from pleural fluids by diethylaminoetyyl cellulose ion exchange nephlometry in patients with undiagnosed effusion after common investigations as it positive in IgG4 related disease. The median effusion IgG4 level was 41mg/dl in the IgG4 positive group and 27mg/dl in the IgG negative group.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1</enrollment>
  <condition>Pleural Effusion</condition>
  <arm_group>
    <arm_group_label>patients with pleural effusion</arm_group_label>
    <description>In patients with pleural effusion that remains undiagnosed with common diagnostic algorithm, immunoglobulin G4 will be done in pleural fluid</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Immunoglobulin G4</intervention_name>
    <description>IgG4 will be purified from pleural fluids by diethylaminoethyl (DEAE)-cellulose ion exchange nephlometry</description>
    <arm_group_label>patients with pleural effusion</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with exudative pleural effusion admitted to Assiut university hospital in period&#xD;
        of October 2017 to October 2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with exudative pleural effusion admitted to Assiut university hospital in&#xD;
             period of October 2017 to October 2018&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with transudative pleural effusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Raafat T Elsokary, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raafat T Elsokary, Prof</last_name>
    <phone>01006155517</phone>
    <email>elsokkary100@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Metwally, Dr.</last_name>
    <phone>01002163907</phone>
    <email>ahmed_80metwally@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Della-Torre E, Lanzillotta M, Doglioni C. Immunology of IgG4-related disease. Clin Exp Immunol. 2015 Aug;181(2):191-206. doi: 10.1111/cei.12641. Epub 2015 Jun 8.</citation>
    <PMID>25865251</PMID>
  </reference>
  <reference>
    <citation>Davies HE, Nicholson JE, Rahman NM, Wilkinson EM, Davies RJ, Lee YC. Outcome of patients with nonspecific pleuritis/fibrosis on thoracoscopic pleural biopsies. Eur J Cardiothorac Surg. 2010 Oct;38(4):472-7. doi: 10.1016/j.ejcts.2010.01.057. Epub 2010 Mar 12.</citation>
    <PMID>20219385</PMID>
  </reference>
  <reference>
    <citation>Ferrer JS, Munoz XG, Orriols RM, Light RW, Morell FB. Evolution of idiopathic pleural effusion: a prospective, long-term follow-up study. Chest. 1996 Jun;109(6):1508-13. doi: 10.1378/chest.109.6.1508.</citation>
    <PMID>8769502</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Nermen Abuelkassem</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulin G</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03260088
org study id: PLEFF
nct id: NCT03260088
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pleural effusion is an accumulation of fluid between the tissue layers that line the lungs
      and chest cavity. It has an estimated prevalence of 320 per 100,000 people in industrialized
      countries. The cause of the pleural effusion remains unclear in a substantial percentage of
      patients with persistently exudative effusions.
They are classified broadly into exudative and transudative effusion based on Light's
      criteria.

      Several methods have been proposed for the identification of pleural effusion etiology
      including pleural fluid cytology, pleural biopsy, thoracoscopy and computerized tomography.
      However, these technologies have their own limitations.

      The diagnosis of malignant pleural effusion is a vexing problem, since pleural fluid cytology
      findings are positive in only 60% of cases on average. Tumor marker carcinoembryonic antigen
      (CEA) can be positive in 80% of cases.

      Thoracoscopy will establish the diagnosis in approximately 95% of cases, but this
      interventional procedure may not be available at all facilities.

      A new approach is needed to detect the cause of undiagnosed pleural effusions. Diagnosis of
      idiopathic pleural effusion was made after a minimum of one year follow up with detailed
      exploration including computed tomographic scanning to exclude other causes of effusion such
      as malignant pleural effusion.

      Because immunoglobulin G4 (IgG4)-related disease is recognized as a fibroinflammatory
      condition of unknown cause that can affect multiple organs including the lungs and pleura,
      IgG4 might be related to certain idiopathic pleural effusions.

      The criteria of Common radiological findings of IgG4-related lung disease include hilar and
      mediastinal lymphadenopathy, thickening of perilymphatic interstitium with or without
      subpleural and/or peribronchovascular consolidation.
observational model: Cohort
time perspective: Prospective
measure: diagnosis new causes of previously remained undiagnosed cases of pleural effusion by using IgG4 in Assiut university hospital
time frame: one year
description: Immunoglobulin G4 will be puified from pleural fluids by diethylaminoetyyl cellulose ion exchange nephlometry in patients with undiagnosed effusion after common investigations as it positive in IgG4 related disease. The median effusion IgG4 level was 41mg/dl in the IgG4 positive group and 27mg/dl in the IgG negative group.
arm group label: patients with pleural effusion
description: In patients with pleural effusion that remains undiagnosed with common diagnostic algorithm, immunoglobulin G4 will be done in pleural fluid
intervention type: Diagnostic Test
intervention name: Immunoglobulin G4
description: IgG4 will be purified from pleural fluids by diethylaminoethyl (DEAE)-cellulose ion exchange nephlometry
arm group label: patients with pleural effusion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Raafat T Elsokary, Prof
role: Study Director
affiliation: Assiut University
last name: Raafat T Elsokary, Prof
phone: 01006155517
email: elsokkary100@yahoo.com
last name: Ahmed Metwally, Dr.
phone: 01002163907
email: ahmed_80metwally@yahoo.com
citation: Della-Torre E, Lanzillotta M, Doglioni C. Immunology of IgG4-related disease. Clin Exp Immunol. 2015 Aug;181(2):191-206. doi: 10.1111/cei.12641. Epub 2015 Jun 8.
PMID: 25865251
citation: Davies HE, Nicholson JE, Rahman NM, Wilkinson EM, Davies RJ, Lee YC. Outcome of patients with nonspecific pleuritis/fibrosis on thoracoscopic pleural biopsies. Eur J Cardiothorac Surg. 2010 Oct;38(4):472-7. doi: 10.1016/j.ejcts.2010.01.057. Epub 2010 Mar 12.
PMID: 20219385
citation: Ferrer JS, Munoz XG, Orriols RM, Light RW, Morell FB. Evolution of idiopathic pleural effusion: a prospective, long-term follow-up study. Chest. 1996 Jun;109(6):1508-13. doi: 10.1378/chest.109.6.1508.
PMID: 8769502
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Nermen Abuelkassem
investigator title: Dr
mesh term: Pleural Effusion
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies
mesh term: Immunoglobulin G
sharing ipd: Undecided