<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/NCT01710930</url>
  </required_header>
  <id_info>
    <org_study_id>RC11_0158</org_study_id>
    <nct_id>NCT01710930</nct_id>
  </id_info>
  <brief_title>Protocol TARC-ABPA</brief_title>
  <official_title>Interest of TARC Serum Marker for Follow-up of Patients With Allergic Broncho-Pulmonary Aspergillosis (ABPA), Excluding Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to determine if a doubling of serum TARC (compared to&#xD;
      baseline) is associated with the occurrence of exacerbations of ABPA.&#xD;
&#xD;
      The secondary objectives of the study are :&#xD;
&#xD;
        1. To investigate if induced sputum eosinophils count (compared to baseline) is associated&#xD;
           with the occurrence of exacerbations.&#xD;
&#xD;
        2. To examine if the exhaled NO (compared to a baseline) is associated with the occurrence&#xD;
           of exacerbations.&#xD;
&#xD;
        3. To investigate if activation of circulating T cells (compared to a baseline) is&#xD;
           associated with the occurrence of exacerbations.&#xD;
&#xD;
        4. To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline)&#xD;
           is associated with the occurrence of exacerbations.&#xD;
&#xD;
        5. To determine if the variation of one of the markers above, TARC or Asp f specific IgE&#xD;
           measured at baseline, may be associated with the radiological stage of the disease&#xD;
           (ABPA-S, ABPA-CB, ABPA-ORF).&#xD;
&#xD;
        6. To investigate if there is a link between fungal exposure at home (visually assessed by&#xD;
           the contamination level and the proportion of positive samples for Asp. f) and the&#xD;
           frequency of exacerbations.&#xD;
&#xD;
        7. To establish if some of the clinical, functional or biological data studied are&#xD;
           associated with the frequency of exacerbations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">September 21, 2017</completion_date>
  <primary_completion_date type="Actual">September 21, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The rate of serum TARC</measure>
    <description>The rate of serum TARC will be measured by ELISA and expressed in pg / ml.Doubling of TARC rate compared between baseline (V1) and exacerbations is the primary endpoint (qualitative binary).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Induced sputum eosinophils count</measure>
    <description>Increase in induced sputum eosinophils count assessed by cytology between baseline visit (V1) and the visit(s) in exacerbation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of Exhaled NO(FeNO50)</measure>
    <description>Increase in exhaled NO (FeNO50) between baseline visit (V1) and the visit (s) in exacerbation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of circulating T cells</measure>
    <description>Increase in circulating T cells activation, measured by the rate of Th1, Th2, Th17, Treg lymphocytes by flow cytometry before and after specific Asp f. stimulation between baseline visit (V1) and the visit (s) in exacerbation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of Aspf. specific serum IgG</measure>
    <description>Increase of Aspf. specific serum IgG, measured by ELISA between baseline visit (V1) and the visit (s) in exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between markers</measure>
    <description>Correlation between previous markers, TARC or specific IgE measured at baseline and the stage of the radiological stage of the disease evaluated at V1 (ABPA-S, ABPA-CB, ABPA-ORF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fungal exposure at home</measure>
    <description>Link of fungal exposure at home with exacerbation frequency and the stage of disease severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clincal parameters</measure>
    <description>Link between the clinical parameters (sex, complex aspergillosis, smoking, body mass index, reached ENT associated (chronic rhinitis, sinonasal-polyposis)) and the frequency of exacerbations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological parameters</measure>
    <description>Link between the biological parameters measured at stable state (V1) (total IgE, Asp fspecific IgE, Aspergillus precipitins) and the frequency of exacerbations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function parameters</measure>
    <description>Link between the function parameters measured at baseline state (FEV1 (in%), FVC (in%), compared RV / TLC, FeNO50) and the frequency of exacerbations.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Allergic Broncho-Pulmonary Aspergillosis</condition>
  <arm_group>
    <arm_group_label>Study of predictive factors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Study of predictive factors</intervention_name>
    <description>Phase 1 : Inclusion of patients (V0) :&#xD;
In the case of a participation agreement, data on age, profession, previous history, history of the disease and current treatments will be collected. Different tests will be performed at this visit.&#xD;
Phase 2 : Determination of the baseline (V1) : Patients will be reviewed one month after V0 (V1). In the absence of exacerbation between V0 and V1, the examinations performed in routine practice will be used to determine the basic state of biological parameters of interest. During this visit, different tests will be performed.&#xD;
Phase 3 : Quarterly monitoring of patients (V2-V9) : Patients will be followed every three months for 2 years (V2-V9).</description>
    <arm_group_label>Study of predictive factors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Pre-inclusion criteria :&#xD;
&#xD;
          -  Major patients, of indifferent sex,&#xD;
&#xD;
          -  Patients insured,&#xD;
&#xD;
          -  Patients accepting to give, after information, their signed informed consent form,&#xD;
&#xD;
          -  Patients affected by ABPA,&#xD;
&#xD;
          -  Patients in remission without treatment, or stable under current treatment for at&#xD;
             least 3 months.&#xD;
&#xD;
        Inclusion criteria :&#xD;
&#xD;
        This inclusion will be definitive in V1, if :&#xD;
&#xD;
          -  The pre-inclusion criteria are respected,&#xD;
&#xD;
          -  The patient has not presented any exacerbation since V0 thereby define a basic state.&#xD;
&#xD;
        If patient could not be included, it will be possible to re-screen him for the study,&#xD;
        provided he meets the pre-inclusion and inclusion criteria. In this case, a new V0 will be&#xD;
        scheduled at least 3 months after the first V0.&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
          -  Minor patients,&#xD;
&#xD;
          -  Adults under guardianship,&#xD;
&#xD;
          -  Pregnant or lactating women,&#xD;
&#xD;
          -  Patients unable to follow the protocol or to give consent,&#xD;
&#xD;
          -  Patients with an infection of the lower respiratory tract in the 4 weeks preceding V0&#xD;
             or between V0 and V1,&#xD;
&#xD;
          -  Patients who were hospitalized for respiratory problems in the 4 weeks preceding V0 or&#xD;
             between V0 and V1,&#xD;
&#xD;
          -  Patients with chronic inflammatory diseases unrelated to ABPA which could influence&#xD;
             the results,&#xD;
&#xD;
          -  Patients with cancer,&#xD;
&#xD;
          -  Patients followed for cystic fibrosis defined by a positive sweat test,&#xD;
&#xD;
          -  Patients with known compliance problems identified prior to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anaïs PIPET, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Nantes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hakima OUKSEL, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Angers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>François GOUPIL, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>CH du Mans</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Le Mans</name>
      <address>
        <city>Le Mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>April 5, 2018</last_update_submitted>
  <last_update_submitted_qc>April 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Allergic Broncho-Pulmonary Aspergillosis</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>
    <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/NCT01710930
org study id: RC11_0158
nct id: NCT01710930
lead sponsor: 
has dmc: Yes
The main objective of this study is to determine if a doubling of serum TARC (compared to
      baseline) is associated with the occurrence of exacerbations of ABPA.

      The secondary objectives of the study are :

        1. To investigate if induced sputum eosinophils count (compared to baseline) is associated
           with the occurrence of exacerbations.

        2. To examine if the exhaled NO (compared to a baseline) is associated with the occurrence
           of exacerbations.

        3. To investigate if activation of circulating T cells (compared to a baseline) is
           associated with the occurrence of exacerbations.

        4. To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline)
           is associated with the occurrence of exacerbations.

        5. To determine if the variation of one of the markers above, TARC or Asp f specific IgE
           measured at baseline, may be associated with the radiological stage of the disease
           (ABPA-S, ABPA-CB, ABPA-ORF).

        6. To investigate if there is a link between fungal exposure at home (visually assessed by
           the contamination level and the proportion of positive samples for Asp. f) and the
           frequency of exacerbations.

        7. To establish if some of the clinical, functional or biological data studied are
           associated with the frequency of exacerbations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The rate of serum TARC
description: The rate of serum TARC will be measured by ELISA and expressed in pg / ml.Doubling of TARC rate compared between baseline (V1) and exacerbations is the primary endpoint (qualitative binary).
measure: Induced sputum eosinophils count
description: Increase in induced sputum eosinophils count assessed by cytology between baseline visit (V1) and the visit(s) in exacerbation.
measure: The rate of Exhaled NO(FeNO50)
description: Increase in exhaled NO (FeNO50) between baseline visit (V1) and the visit (s) in exacerbation.
measure: The rate of circulating T cells
description: Increase in circulating T cells activation, measured by the rate of Th1, Th2, Th17, Treg lymphocytes by flow cytometry before and after specific Asp f. stimulation between baseline visit (V1) and the visit (s) in exacerbation.
measure: The rate of Aspf. specific serum IgG
description: Increase of Aspf. specific serum IgG, measured by ELISA between baseline visit (V1) and the visit (s) in exacerbation
measure: Correlation between markers
description: Correlation between previous markers, TARC or specific IgE measured at baseline and the stage of the radiological stage of the disease evaluated at V1 (ABPA-S, ABPA-CB, ABPA-ORF).
measure: Fungal exposure at home
description: Link of fungal exposure at home with exacerbation frequency and the stage of disease severity.
measure: Clincal parameters
description: Link between the clinical parameters (sex, complex aspergillosis, smoking, body mass index, reached ENT associated (chronic rhinitis, sinonasal-polyposis)) and the frequency of exacerbations.
measure: Biological parameters
description: Link between the biological parameters measured at stable state (V1) (total IgE, Asp fspecific IgE, Aspergillus precipitins) and the frequency of exacerbations.
measure: Function parameters
description: Link between the function parameters measured at baseline state (FEV1 (in%), FVC (in%), compared RV / TLC, FeNO50) and the frequency of exacerbations.
arm group label: Study of predictive factors
arm group type: Experimental
intervention type: Other
intervention name: Study of predictive factors
description: Phase 1 : Inclusion of patients (V0) :
In the case of a participation agreement, data on age, profession, previous history, history of the disease and current treatments will be collected. Different tests will be performed at this visit.
Phase 2 : Determination of the baseline (V1) : Patients will be reviewed one month after V0 (V1). In the absence of exacerbation between V0 and V1, the examinations performed in routine practice will be used to determine the basic state of biological parameters of interest. During this visit, different tests will be performed.
Phase 3 : Quarterly monitoring of patients (V2-V9) : Patients will be followed every three months for 2 years (V2-V9).
arm group label: Study of predictive factors
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anaïs PIPET, Doctor
role: Principal Investigator
affiliation: CHU de Nantes
last name: Hakima OUKSEL, Doctor
role: Study Chair
affiliation: University Hospital, Angers
last name: François GOUPIL, Doctor
role: Study Chair
affiliation: CH du Mans
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Aspergillosis
mesh term: Pulmonary Aspergillosis
mesh term: Aspergillosis, Allergic Bronchopulmonary