<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/NCT04435678</url>
  </required_header>
  <id_info>
    <org_study_id>32-332 ex 19/20</org_study_id>
    <nct_id>NCT04435678</nct_id>
  </id_info>
  <brief_title>Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens</brief_title>
  <acronym>MADMAX</acronym>
  <official_title>Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MacroArray Diagnostics GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MacroArray Diagnostics GmbH</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>
      About 20% of the general population are affected by an allergy - with an upward trend. Quite&#xD;
      often, allergic people do not consider their disease as serious and suffer from subsequent&#xD;
      complications, like allergic asthma, later in their life. The sooner the allergen source is&#xD;
      identified, the sooner the therapeutic intervention (e.g. dietary recommendations, allergen&#xD;
      avoidance, anti-inflammatory treatment or allergen immunotherapy) can be started.&#xD;
      Cross-reactivity may also play an important role. Therefore, a comprehensive allergy test is&#xD;
      essential for an optimal treatment of patients.&#xD;
&#xD;
      Modern multiplex testing is an individualized diagnostic approach, which may help to identify&#xD;
      eligible patients for allergen immunotherapy and may identify risk groups by analyzing the&#xD;
      sIgE profile. Until now, published data on the clinical usability of multiplex allergy&#xD;
      diagnostic test systems are often limited. Even though, available studies show a good&#xD;
      correlation between conventionally used multiplex or singleplex assays (ISAC or ImmunoCAP)&#xD;
      and the new multiplex assay (ALEX and ALEX²), the results are often based on small sample&#xD;
      sizes investigating many different allergens.&#xD;
&#xD;
      Therefore, this clinical performance study is conducted to evaluate the diagnostic accuracy&#xD;
      of the ALEX² IgE multiplex test using the Multi Array Explorer (MAX 45k, MacroArray&#xD;
      Diagnostics) automated laboratory system in comparison to a conventional IgE singleplex test&#xD;
      system as well as clinical symptoms and skin prick test results in a total of 826 patients.&#xD;
      Patients with the most common inhalant allergies (e.g. grass pollen, house dust mite or cat&#xD;
      allergy) will be included as well as patients suffering from Hymenoptera venom allergy, which&#xD;
      is the major cause of anaphylaxis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Actual">April 12, 2022</completion_date>
  <primary_completion_date type="Actual">April 12, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>diagnostic accuracy (sensitivity, specificity) of the MAX 45k/ALEX² IgE multiplex test</measure>
    <time_frame>1 day</time_frame>
    <description>Sensitivity and specificity of the sIgE status determined by the MAX 45k/ALEX² IgE multiplex test (positive, if ≥0.30 kUA/L) compared to allergy status according to clinical symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin test</measure>
    <time_frame>1 day</time_frame>
    <description>Sensitivity and specificity of the sIgE status determined by the MAX 45k/ALEX² IgE multiplex test compared to allergy status according to skin test results (specific for suspected allergy)</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">839</enrollment>
  <condition>Birch Pollen Allergy</condition>
  <condition>Grass Pollen Allergy</condition>
  <condition>House Dust Mite Allergy</condition>
  <condition>Cat Allergy</condition>
  <condition>Bee Venom Allergy</condition>
  <condition>Vespid Venom Allergy</condition>
  <arm_group>
    <arm_group_label>birch pollen allergy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>106 patients with suspicion of birch pollen allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.&#xD;
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>grass pollen allergy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>106 patients with suspicion of grass pollen allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.&#xD;
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>house dust mite allergy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>148 patients with suspicion of house dust mite allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.&#xD;
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cat allergy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>106 patients with suspicion of cat allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.&#xD;
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bee venom allergy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>106 patients with suspicion of bee venom allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and an intradermal test will be performed.&#xD;
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vespid venom allergy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>106 patients with suspicion of vespid venom allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and an intradermal test will be performed.&#xD;
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-allergic individuals</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>148 non-allergic individuals will be included in the study. They should have no symptoms that could be related to inhalant allergy or Hymenoptera venom allergy, negative skin test results and undetectable IgE levels.&#xD;
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ALEX² test using the MAX 45k automated laboratory system</intervention_name>
    <description>The ALEX² test system is a quantitative in vitro diagnostic (IVD) test for the measurement of allergen specific IgE (sIgE) and a semi-quantitative in vitro diagnostic test for the measurement of total IgE (tIgE) in human serum or plasma (exception EDTA plasma).&#xD;
The MAX 45k analyzer is intended for an automated in-vitro diagnostics use for quantitative determination of allergen specific Immunoglobulin E and semi-quantitative determination of total IgE. The MAX 45k is suitable for human serum or plasma (Heparin, Citrat, but no EDTA). MAX 45k is intended to be used only in conjunction with RAPTOR SERVER analysis software and ALEX based technology arrays.</description>
    <arm_group_label>bee venom allergy</arm_group_label>
    <arm_group_label>birch pollen allergy</arm_group_label>
    <arm_group_label>cat allergy</arm_group_label>
    <arm_group_label>grass pollen allergy</arm_group_label>
    <arm_group_label>house dust mite allergy</arm_group_label>
    <arm_group_label>non-allergic individuals</arm_group_label>
    <arm_group_label>vespid venom allergy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects with suspicion of allergy&#xD;
&#xD;
          -  Written consent of the participant (and/or his/her parent or legal representative)&#xD;
             after being informed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oral treatment with corticosteroids (&gt;5mg/day)&#xD;
&#xD;
          -  Treatment with antihistamines (histamine (H1) receptor blockers)&#xD;
&#xD;
          -  Hematological disease (coagulation disorders, anemia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Dermatology and Venerology, Medical University of Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Outpatient Clinic Reumannplatz</name>
      <address>
        <city>Vienna</city>
        <zip>1100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis, Allergic, Seasonal</mesh_term>
    <mesh_term>Dust Mite Allergy</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Venom Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 19, 2022</submitted>
    <returned>August 31, 2023</returned>
  </pending_results>
  <!-- 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/NCT04435678
org study id: 32-332 ex 19/20
nct id: NCT04435678
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
About 20% of the general population are affected by an allergy - with an upward trend. Quite
      often, allergic people do not consider their disease as serious and suffer from subsequent
      complications, like allergic asthma, later in their life. The sooner the allergen source is
      identified, the sooner the therapeutic intervention (e.g. dietary recommendations, allergen
      avoidance, anti-inflammatory treatment or allergen immunotherapy) can be started.
      Cross-reactivity may also play an important role. Therefore, a comprehensive allergy test is
      essential for an optimal treatment of patients.

      Modern multiplex testing is an individualized diagnostic approach, which may help to identify
      eligible patients for allergen immunotherapy and may identify risk groups by analyzing the
      sIgE profile. Until now, published data on the clinical usability of multiplex allergy
      diagnostic test systems are often limited. Even though, available studies show a good
      correlation between conventionally used multiplex or singleplex assays (ISAC or ImmunoCAP)
      and the new multiplex assay (ALEX and ALEX²), the results are often based on small sample
      sizes investigating many different allergens.

      Therefore, this clinical performance study is conducted to evaluate the diagnostic accuracy
      of the ALEX² IgE multiplex test using the Multi Array Explorer (MAX 45k, MacroArray
      Diagnostics) automated laboratory system in comparison to a conventional IgE singleplex test
      system as well as clinical symptoms and skin prick test results in a total of 826 patients.
      Patients with the most common inhalant allergies (e.g. grass pollen, house dust mite or cat
      allergy) will be included as well as patients suffering from Hymenoptera venom allergy, which
      is the major cause of anaphylaxis.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: diagnostic accuracy (sensitivity, specificity) of the MAX 45k/ALEX² IgE multiplex test
time frame: 1 day
description: Sensitivity and specificity of the sIgE status determined by the MAX 45k/ALEX² IgE multiplex test (positive, if ≥0.30 kUA/L) compared to allergy status according to clinical symptoms.
measure: Skin test
time frame: 1 day
description: Sensitivity and specificity of the sIgE status determined by the MAX 45k/ALEX² IgE multiplex test compared to allergy status according to skin test results (specific for suspected allergy)
arm group label: birch pollen allergy
arm group type: Other
description: 106 patients with suspicion of birch pollen allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).
arm group label: grass pollen allergy
arm group type: Other
description: 106 patients with suspicion of grass pollen allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).
arm group label: house dust mite allergy
arm group type: Other
description: 148 patients with suspicion of house dust mite allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system)
arm group label: cat allergy
arm group type: Other
description: 106 patients with suspicion of cat allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and a skin prick test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).
arm group label: bee venom allergy
arm group type: Other
description: 106 patients with suspicion of bee venom allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and an intradermal test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).
arm group label: vespid venom allergy
arm group type: Other
description: 106 patients with suspicion of vespid venom allergy will be included in the study. For routine diagnosis, blood samples will be taken to determine total IgE and specific IgE and an intradermal test will be performed.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).
arm group label: non-allergic individuals
arm group type: Other
description: 148 non-allergic individuals will be included in the study. They should have no symptoms that could be related to inhalant allergy or Hymenoptera venom allergy, negative skin test results and undetectable IgE levels.
Left over blood samples will be used to perform the additional allergy test (ALEX² test using the MAX 45k automated laboratory system).
intervention type: Diagnostic Test
intervention name: ALEX² test using the MAX 45k automated laboratory system
description: The ALEX² test system is a quantitative in vitro diagnostic (IVD) test for the measurement of allergen specific IgE (sIgE) and a semi-quantitative in vitro diagnostic test for the measurement of total IgE (tIgE) in human serum or plasma (exception EDTA plasma).
The MAX 45k analyzer is intended for an automated in-vitro diagnostics use for quantitative determination of allergen specific Immunoglobulin E and semi-quantitative determination of total IgE. The MAX 45k is suitable for human serum or plasma (Heparin, Citrat, but no EDTA). MAX 45k is intended to be used only in conjunction with RAPTOR SERVER analysis software and ALEX based technology arrays.
arm group label: bee venom allergy
arm group label: birch pollen allergy
arm group label: cat allergy
arm group label: grass pollen allergy
arm group label: house dust mite allergy
arm group label: non-allergic individuals
arm group label: vespid venom allergy
criteria: 
gender: All
minimum age: 0 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Rhinitis, Allergic, Seasonal
mesh term: Dust Mite Allergy
mesh term: Hypersensitivity
mesh term: Venom Hypersensitivity
sharing ipd: No
submitted: October 19, 2022
returned: August 31, 2023