<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/NCT03267394</url>
  </required_header>
  <id_info>
    <org_study_id>TARC in diagnosis of ABPA</org_study_id>
    <nct_id>NCT03267394</nct_id>
  </id_info>
  <brief_title>Role of Thymus-And Activation-Regulated Chemokine (TARC) In Diagnosis Of Allergic Bronchopulmonary Aspergillosis</brief_title>
  <official_title>Role of Thymus-And Activation-Regulated Chemokine (TARC) In Diagnosis Of Allergic Bronchopulmonary Aspergillosis</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>
      This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary&#xD;
      Aspergillosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Allergic bronchopulmonary Aspergillosis (ABPA) is a pulmonary hypersensitivity disease&#xD;
      mediated by an allergic response to Aspergillus fumigates. ABPA occurs in, 10% of cystic&#xD;
      fibrosis (CF) patients and may lead to acute worsening of respiratory status and ongoing&#xD;
      decline in lung function, ultimately progressing to a chronic state and lung fibrosis without&#xD;
      adequate treatment. Despite the existence of the gold-standard Nelson criteria, diagnosis of&#xD;
      ABPA in CF patients remains difficult. The wide variation in diagnostic practices between&#xD;
      clinics, different estimates of prevalence and a delay in recognition lead to under treatment&#xD;
      (Virnig and Bush 2007).&#xD;
&#xD;
      The main reason for the difficulties in diagnosis of ABPA and ABPA exacerbations in CF&#xD;
      patients is the overlap of diagnostic criteria for ABPA with common manifestations of CF.&#xD;
      Pulmonary infiltrates, obstructive lung disease and bronchiectasis occur regularly in CF&#xD;
      patients, due to the underlying disease with bacterial colonisation, and thus are not&#xD;
      specific to ABPA. Furthermore lung colonisation with A. fumigatus occurs in 20-25% of CF&#xD;
      patients. Therefore, as stated in the most recent consensus document on diagnosis and therapy&#xD;
      of ABPA in CF patients, serological findings should contribute strongly to the confirmation&#xD;
      or exclusion of clinically suspected ABPA (Stevens, Moss et al. 2003).&#xD;
&#xD;
      The diagnosis of allergic bronchopulmonary Aspergillosis (ABPA) in cystic fibrosis (CF) is a&#xD;
      challenge. Thymus- and activation-regulated chemokine (TARC) has recently been reported to&#xD;
      play a role in ABPA (Latzin, Hartl et al. 2008).&#xD;
&#xD;
      TARC levels (analyzed by sandwich ELISA) increased early in the course of ABPA, before total&#xD;
      IgE elevation, with an inverse correlation between TARC levels and spirometric parameters&#xD;
      (FEV 1) identified in CF patient with ABPA. Elevated TARC level was strongly correlated with&#xD;
      the level of rAsp f4 in ABPA patients, while no association was found with the other&#xD;
      recombinants (rAsp f1, f2, f3 and f6). This biomarker showed a greater test accuracy for ABPA&#xD;
      diagnosis than all other biological markers tested (total IgE, specific c IgG and antibodies&#xD;
      against recombinants allergens rAsp f1, rAsp f3, rAsp f4 and rAsp f6). It seems to be able to&#xD;
      differentiate CF patients with ABPA from those colonized or sensitized to A. fumigatus.&#xD;
      Furthermore, corticotherapy decreases the TARC secretion, producing a rapid decrease of serum&#xD;
      TARC level that can be used to follow patient evolution as well as the effect of&#xD;
      corticosteroid therapy in ABPA (Delhaes, Frealle et al. 2010).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">October 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>thymus and activation regulated chemokine (TARC) in diagnosis of Allergic bronchopulmonary aspergellosis</measure>
    <time_frame>base line</time_frame>
    <description>This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary Aspergillosis.</description>
  </primary_outcome>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Thymus and Activation Regulated Chemokine</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The included patients will be subjected to:&#xD;
&#xD;
          1. History and clinical examination.&#xD;
&#xD;
          2. Spirometry and reversibility test.&#xD;
&#xD;
          3. Radiological investigation:&#xD;
&#xD;
               -  Plain chest X-ray.&#xD;
&#xD;
               -  Chest HRCT chest.&#xD;
&#xD;
          4. Laboratory investigations including:&#xD;
&#xD;
               -  Routine lab. Investigation: (CBC, liver function tests, renal function tests).&#xD;
&#xD;
               -  Serum eosinophilia.&#xD;
&#xD;
               -  Immunological investigations:&#xD;
&#xD;
                    -  Total IGE.&#xD;
&#xD;
                    -  New marker thymus-and activation-regulated chemokine (TARC).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • In this study patients referred from chest department for diagnosis of allergic&#xD;
             pulmonary Aspergillosis will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Pregnancy&#xD;
&#xD;
               -  Lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>hager Sayed, clinical pathology resident</last_name>
    <phone>01069199343</phone>
    <email>hs11492@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohammed Ismail</last_name>
    <phone>01020058069</phone>
    <email>moh_ismail310@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Virnig C, Bush RK. Allergic bronchopulmonary aspergillosis: a US perspective. Curr Opin Pulm Med. 2007 Jan;13(1):67-71. doi: 10.1097/MCP.0b013e328010c812.</citation>
    <PMID>17133128</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Hager sayed</investigator_full_name>
    <investigator_title>Egypt-Assiut</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspergillosis</mesh_term>
    <mesh_term>Pulmonary Aspergillosis</mesh_term>
    <mesh_term>Aspergillosis, Allergic Bronchopulmonary</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/NCT03267394
org study id: TARC in diagnosis of ABPA
nct id: NCT03267394
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary
      Aspergillosis.
Allergic bronchopulmonary Aspergillosis (ABPA) is a pulmonary hypersensitivity disease
      mediated by an allergic response to Aspergillus fumigates. ABPA occurs in, 10% of cystic
      fibrosis (CF) patients and may lead to acute worsening of respiratory status and ongoing
      decline in lung function, ultimately progressing to a chronic state and lung fibrosis without
      adequate treatment. Despite the existence of the gold-standard Nelson criteria, diagnosis of
      ABPA in CF patients remains difficult. The wide variation in diagnostic practices between
      clinics, different estimates of prevalence and a delay in recognition lead to under treatment
      (Virnig and Bush 2007).

      The main reason for the difficulties in diagnosis of ABPA and ABPA exacerbations in CF
      patients is the overlap of diagnostic criteria for ABPA with common manifestations of CF.
      Pulmonary infiltrates, obstructive lung disease and bronchiectasis occur regularly in CF
      patients, due to the underlying disease with bacterial colonisation, and thus are not
      specific to ABPA. Furthermore lung colonisation with A. fumigatus occurs in 20-25% of CF
      patients. Therefore, as stated in the most recent consensus document on diagnosis and therapy
      of ABPA in CF patients, serological findings should contribute strongly to the confirmation
      or exclusion of clinically suspected ABPA (Stevens, Moss et al. 2003).

      The diagnosis of allergic bronchopulmonary Aspergillosis (ABPA) in cystic fibrosis (CF) is a
      challenge. Thymus- and activation-regulated chemokine (TARC) has recently been reported to
      play a role in ABPA (Latzin, Hartl et al. 2008).

      TARC levels (analyzed by sandwich ELISA) increased early in the course of ABPA, before total
      IgE elevation, with an inverse correlation between TARC levels and spirometric parameters
      (FEV 1) identified in CF patient with ABPA. Elevated TARC level was strongly correlated with
      the level of rAsp f4 in ABPA patients, while no association was found with the other
      recombinants (rAsp f1, f2, f3 and f6). This biomarker showed a greater test accuracy for ABPA
      diagnosis than all other biological markers tested (total IgE, specific c IgG and antibodies
      against recombinants allergens rAsp f1, rAsp f3, rAsp f4 and rAsp f6). It seems to be able to
      differentiate CF patients with ABPA from those colonized or sensitized to A. fumigatus.
      Furthermore, corticotherapy decreases the TARC secretion, producing a rapid decrease of serum
      TARC level that can be used to follow patient evolution as well as the effect of
      corticosteroid therapy in ABPA (Delhaes, Frealle et al. 2010).
observational model: Cohort
time perspective: Prospective
measure: thymus and activation regulated chemokine (TARC) in diagnosis of Allergic bronchopulmonary aspergellosis
time frame: base line
description: This study aims to assess the value of TARC in diagnosis of allergic Bronchopulmonary Aspergillosis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: hager Sayed, clinical pathology resident
phone: 01069199343
email: hs11492@yahoo.com
last name: Mohammed Ismail
phone: 01020058069
email: moh_ismail310@yahoo.com
citation: Virnig C, Bush RK. Allergic bronchopulmonary aspergillosis: a US perspective. Curr Opin Pulm Med. 2007 Jan;13(1):67-71. doi: 10.1097/MCP.0b013e328010c812.
PMID: 17133128
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Hager sayed
investigator title: Egypt-Assiut
mesh term: Aspergillosis
mesh term: Pulmonary Aspergillosis
mesh term: Aspergillosis, Allergic Bronchopulmonary