<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/NCT04442932</url>
  </required_header>
  <id_info>
    <org_study_id>AB-ALL-003.2</org_study_id>
    <nct_id>NCT04442932</nct_id>
  </id_info>
  <brief_title>abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies</brief_title>
  <official_title>Validation of the abioSCOPE Device With an IgE Test Panel: Clinical Sensitivity and Specificity Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abionic SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NAMSA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Abionic SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, prospective, observational study designed to determine the clinical&#xD;
      sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on&#xD;
      Abionic's abioSCOPE device using K3-EDTA anticoagulated plasma samples from atopic and&#xD;
      non-atopic pediatric and adult patients. Patients' sensitization determined with the&#xD;
      abioSCOPE will be compared to the clinical assessment of allergy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor financial has been stopped.&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 15, 2020</start_date>
  <completion_date type="Anticipated">March 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Sensitivity and Specificity of the abioSCOPE</measure>
    <time_frame>Day 1</time_frame>
    <description>The primary objective will be evaluated by estimating the Sensitivity and Specificity of the abioSCOPE to detect sensitization to each of the five allergens or group of allergens. The estimates will be accompanied by 95% Clopper-Pearson Confidence Intervals. The acceptance criteria will be compared to the lower bound of the 95% confidence interval. The ability of the abioSCOPE to detect sensitization to each allergen will be considered acceptable if both the sensitivity and specificity of the allergen meet both performance goals.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Determination of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization.</measure>
    <time_frame>Day 1</time_frame>
    <description>Presentation of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization based of the classification of 40 subjects for each allergen.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Allergy</condition>
  <condition>Allergic Asthma</condition>
  <condition>Allergy to Cats</condition>
  <condition>Allergy to House Dust</condition>
  <condition>Allergy to Dog Dander</condition>
  <condition>Allergy Cockroach</condition>
  <arm_group>
    <arm_group_label>Interventions</arm_group_label>
    <description>Per test, a minimum of 40 atopic subjects for a given allergy and a total of at least 100 non-atopic subjects. To ensure that sufficient subjects with valid results are enrolled, the atopic enrollment goal per allergy is approximately 50 subjects. For each allergen, approximately 20% of the samples must be in the range of 0.70 to 3.5 IUA/mL and the remainder must cover a measuring range that is representative of the target population. Results from a single positive subject can be used in the analyses of more than one allergen if the subject is sensitized for more than one allergen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood Collection</intervention_name>
    <description>K3-EDTA venous whole blood 9 mL 1 venous draw</description>
    <arm_group_label>Interventions</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        • Per test, a minimum of 40 atopic subjects for a given allergy and a total of at least 100&#xD;
        non-atopic subjects (). To ensure that sufficient subjects with valid results are enrolled,&#xD;
        the atopic enrollment goal per allergy is approximately 50 subjects. For each allergen,&#xD;
        approximately 20% of the samples must be in the range of 0.70 to 3.5 IUA/mL and the&#xD;
        remainder must cover a measuring range that is representative of the target population.&#xD;
        Results from a single positive subject can be used in the analyses of more than one&#xD;
        allergen if the subject is sensitized for more than one allergen.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Atopic and non-atopic individuals are needed for this study. For enrollment in the atopic&#xD;
        arm, patients must meet all of the inclusion criteria listed below to be eligible for&#xD;
        participation:&#xD;
&#xD;
          1. Provide signed and dated written informed consent by patient or legally designated&#xD;
             representative prior to any mandatory study-specific procedures, sample collection, or&#xD;
             analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and&#xD;
             less than 18 years of age.&#xD;
&#xD;
          2. Male or female, ≥ 6 years of age.&#xD;
&#xD;
          3. Consulting for signs and/or symptoms of IgE-mediated allergies to perennial allergens.&#xD;
&#xD;
        For enrollment in the non-atopic arm, patients must meet all of the inclusion criteria list&#xD;
        below to be eligible for participation:&#xD;
&#xD;
          1. Provide signed and dated written informed consent by patient or legally designated&#xD;
             representative prior to any mandatory study-specific procedures, sample collection, or&#xD;
             analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and&#xD;
             less than 18 years of age.&#xD;
&#xD;
          2. Male or female, ≥ 6 years of age.&#xD;
&#xD;
          3. Apparently healthy individuals who exhibit no signs/symptoms of IgE-mediated allergies&#xD;
             including rhinitis, conjunctivitis, asthma, eczema, urticaria or food allergy symptoms&#xD;
             upon exposure to animal danders, dust mites, cockroaches, pollens or food allergens&#xD;
             (non-atopic).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients must not meet any exclusion criteria below to be eligible for participation:&#xD;
&#xD;
          1. Patient participating in another study that may influence test results.&#xD;
&#xD;
          2. Subjects taking any of the following medications: antihistamines in the week preceding&#xD;
             the consultation, systemic steroids (inhaled or nasal steroids are allowed),&#xD;
             anti-cytokines or cytokines, systemic interferon (injection local interferon α for the&#xD;
             treatment of HPV is allowed), anti-IgE therapy (approved or investigational) or&#xD;
             treated with systemic chemotherapy.&#xD;
&#xD;
          3. On-going allergen immunotherapy or prior allergen immunotherapy within the prior 3&#xD;
             years.&#xD;
&#xD;
          4. Patient with a history of cancer, autoimmune, or immune deficiency disease.&#xD;
&#xD;
          5. Patient suffering from a hematological pathology (coagulation disorder, severe anemia)&#xD;
             that could interfere with the blood test.&#xD;
&#xD;
          6. Known severe allergic reaction to any of the IVD CAPSULE Allergic Asthma panel&#xD;
             allergen components&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>George Washington University, Washington DC</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University, Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Creticos Research Group, LLC</name>
      <address>
        <city>Crownsville</city>
        <state>Maryland</state>
        <zip>20132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Bernstein Clinical Research Center Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>October 1, 2020</last_update_submitted>
  <last_update_submitted_qc>October 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Allergy</keyword>
  <keyword>Asthma</keyword>
  <keyword>Point-of-Care</keyword>
  <keyword>Immunoassay</keyword>
  <keyword>In vitro Diagnostic</keyword>
  <keyword>Total IgE</keyword>
  <keyword>Specific allergy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_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/NCT04442932
org study id: AB-ALL-003.2
nct id: NCT04442932
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This is a multicenter, prospective, observational study designed to determine the clinical
      sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on
      Abionic's abioSCOPE device using K3-EDTA anticoagulated plasma samples from atopic and
      non-atopic pediatric and adult patients. Patients' sensitization determined with the
      abioSCOPE will be compared to the clinical assessment of allergy.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity and Specificity of the abioSCOPE
time frame: Day 1
description: The primary objective will be evaluated by estimating the Sensitivity and Specificity of the abioSCOPE to detect sensitization to each of the five allergens or group of allergens. The estimates will be accompanied by 95% Clopper-Pearson Confidence Intervals. The acceptance criteria will be compared to the lower bound of the 95% confidence interval. The ability of the abioSCOPE to detect sensitization to each allergen will be considered acceptable if both the sensitivity and specificity of the allergen meet both performance goals.
measure: Determination of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization.
time frame: Day 1
description: Presentation of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization based of the classification of 40 subjects for each allergen.
arm group label: Interventions
description: Per test, a minimum of 40 atopic subjects for a given allergy and a total of at least 100 non-atopic subjects. To ensure that sufficient subjects with valid results are enrolled, the atopic enrollment goal per allergy is approximately 50 subjects. For each allergen, approximately 20% of the samples must be in the range of 0.70 to 3.5 IUA/mL and the remainder must cover a measuring range that is representative of the target population. Results from a single positive subject can be used in the analyses of more than one allergen if the subject is sensitized for more than one allergen.
intervention type: Device
intervention name: Blood Collection
description: K3-EDTA venous whole blood 9 mL 1 venous draw
arm group label: Interventions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypersensitivity
sharing ipd: Undecided