<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/NCT01666288</url>
  </required_header>
  <id_info>
    <org_study_id>2012P000683</org_study_id>
    <nct_id>NCT01666288</nct_id>
  </id_info>
  <brief_title>The Metabolomics of Anaphylaxis to Immunotherapy</brief_title>
  <official_title>The Metabolomics of Anaphylaxis to Immunotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anaphylaxis is defined as a serious allergic reaction mediated by IgE that is often difficult&#xD;
      to diagnose due to the wide heterogeneity of clinical manifestations. The inciting agent is&#xD;
      often difficult to pinpoint and may include food, environmental allergens in patients&#xD;
      undergoing allergen immunotherapy, insect stings, and medications. Evidence of allergy by&#xD;
      demonstration of a positive skin test to the inciting agent, is helpful only if skin testing&#xD;
      is available. The only diagnostic modality that is useful in the diagnosis of anaphylaxis&#xD;
      when IgE skin testing is not available and the inciting agent is unknown, is an elevated&#xD;
      serum tryptase level. However, a diagnosis of anaphylaxis can be made without a tryptase&#xD;
      level or if the tryptase level is normal. A simple, non-invasive test for patients with&#xD;
      anaphylaxis is not currently available and would be helpful to diagnose and to guide further&#xD;
      management options.&#xD;
&#xD;
      Patients who develop anaphylaxis to environmental allergens or venoms during routine&#xD;
      outpatient subcutaneous allergen or venom immunotherapy are an ideal population to study as&#xD;
      we are able to evaluate these specific reactions in a controlled, clinical environment.&#xD;
      Although anaphylaxis is uncommon, the incidence has been estimated to vary between 0.01 and 4&#xD;
      percent of all allergy injections. Subcutaneous allergen or venom immunotherapies are a well&#xD;
      established form of therapy for patients with allergic rhinitis, allergic asthma, or a&#xD;
      confirmed sensitivity to stinging insects. Serial blood sampling can be performed in this&#xD;
      group of patients during a reaction and at baseline one week after a reaction, thereby&#xD;
      allowing each patient to serve as his or her own biological control.&#xD;
&#xD;
      Metabolomics is the study of metabolic pathways and the unique biochemical molecules which&#xD;
      result from the regulatory response to physiological stressors, disease processes, drug&#xD;
      therapy, or allergen or venom immunotherapy. By measuring changes in metabolite&#xD;
      concentrations, the range of biochemical effects and therapeutic intervention can be&#xD;
      determined.&#xD;
&#xD;
      The investigator plans to use metabolic profiling of blood samples collected at the time of&#xD;
      anaphylaxis and one week after, to see if a simple, non-invasive test for patients with&#xD;
      anaphylaxis could be developed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    We are closing the study because of lack of enrollment.&#xD;
  </why_stopped>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">August 14, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in metabolic profile of blood serum metabolites from time of allergen/ venom immunotherapy reaction to one week post-reaction</measure>
    <time_frame>time of reaction to allergen or venom immunotherapy, one week post-reaction</time_frame>
    <description>Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Anaphylaxis as a Result of Allergen or Venom Immunotherapy</condition>
  <arm_group>
    <arm_group_label>IT Anaphylaxis</arm_group_label>
    <description>Blood samples will be taken from patient that develop anaphylaxis to routine outpatient allergen or venom immunotherapy.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma will be collected and retained from whole blood samples that are spun.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients ages 18-75, undergoing routine outpatient subcutaneous environmental allergen&#xD;
        and/or venom immunotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females age 18-75 who are receiving routine outpatient subcutaneous allergen&#xD;
             and/or venom immunotherapy and who meet the World Allergy Organization (WAO) criteria&#xD;
             for anaphylaxis (below):&#xD;
&#xD;
        Has at least ONE of the following three criteria:&#xD;
&#xD;
          1. Acute onset of an illness with involvement of the skin, mucosal tissue, or both (eg,&#xD;
             generalized urticaria, itching or flushing, swollen lips-tongue-uvula)&#xD;
&#xD;
             AND AT LEAST ONE OF THE FOLLOWING:&#xD;
&#xD;
             A) Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF,&#xD;
             hypoxemia) B) Reduced blood pressure or associated symptoms of end-organ dysfunction&#xD;
             (eg. Hypotonia, collapse, syncope, incontinence)&#xD;
&#xD;
             OR&#xD;
&#xD;
          2. Two or more of the following that occur rapidly after exposure to a known allergen for&#xD;
             that patient&#xD;
&#xD;
             A) Involvement of the skin-mucosal tissue (eg, generalized urticaria, itch-flush,&#xD;
             swollen lips-tongue-uvula)&#xD;
&#xD;
             B) Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF,&#xD;
             hypoxemia)&#xD;
&#xD;
             C) Reduced blood pressure or associated symptoms (eg, hypotonia, collapse,, syncope,&#xD;
             incontinence)&#xD;
&#xD;
             D) Persistent gastrointestinal symptoms (eg, crampy abdominal pain, vomiting)&#xD;
&#xD;
             OR&#xD;
&#xD;
          3. Reduced blood pressure after exposure to known allergen for that patient with systolic&#xD;
             blood pressure of less than 90 mm Hg or greater than 30% decrease from that person's&#xD;
             baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy/breastfeeding or possibility of poor compliance to subcutaneous allergen or&#xD;
             venom immunotherapy.&#xD;
&#xD;
          -  Does not meet the WAO criteria for anaphylaxis (above)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aleena S Banerji, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital - Allergy Associates</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Aleena Banerji</investigator_full_name>
    <investigator_title>MD, Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anaphylaxis</mesh_term>
    <mesh_term>Shock</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/NCT01666288
org study id: 2012P000683
nct id: NCT01666288
lead sponsor: 
has dmc: No
Anaphylaxis is defined as a serious allergic reaction mediated by IgE that is often difficult
      to diagnose due to the wide heterogeneity of clinical manifestations. The inciting agent is
      often difficult to pinpoint and may include food, environmental allergens in patients
      undergoing allergen immunotherapy, insect stings, and medications. Evidence of allergy by
      demonstration of a positive skin test to the inciting agent, is helpful only if skin testing
      is available. The only diagnostic modality that is useful in the diagnosis of anaphylaxis
      when IgE skin testing is not available and the inciting agent is unknown, is an elevated
      serum tryptase level. However, a diagnosis of anaphylaxis can be made without a tryptase
      level or if the tryptase level is normal. A simple, non-invasive test for patients with
      anaphylaxis is not currently available and would be helpful to diagnose and to guide further
      management options.

      Patients who develop anaphylaxis to environmental allergens or venoms during routine
      outpatient subcutaneous allergen or venom immunotherapy are an ideal population to study as
      we are able to evaluate these specific reactions in a controlled, clinical environment.
      Although anaphylaxis is uncommon, the incidence has been estimated to vary between 0.01 and 4
      percent of all allergy injections. Subcutaneous allergen or venom immunotherapies are a well
      established form of therapy for patients with allergic rhinitis, allergic asthma, or a
      confirmed sensitivity to stinging insects. Serial blood sampling can be performed in this
      group of patients during a reaction and at baseline one week after a reaction, thereby
      allowing each patient to serve as his or her own biological control.

      Metabolomics is the study of metabolic pathways and the unique biochemical molecules which
      result from the regulatory response to physiological stressors, disease processes, drug
      therapy, or allergen or venom immunotherapy. By measuring changes in metabolite
      concentrations, the range of biochemical effects and therapeutic intervention can be
      determined.

      The investigator plans to use metabolic profiling of blood samples collected at the time of
      anaphylaxis and one week after, to see if a simple, non-invasive test for patients with
      anaphylaxis could be developed.
observational model: Case-Only
time perspective: Prospective
measure: Change in metabolic profile of blood serum metabolites from time of allergen/ venom immunotherapy reaction to one week post-reaction
time frame: time of reaction to allergen or venom immunotherapy, one week post-reaction
description: Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes
arm group label: IT Anaphylaxis
description: Blood samples will be taken from patient that develop anaphylaxis to routine outpatient allergen or venom immunotherapy.
Plasma will be collected and retained from whole blood samples that are spun.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Aleena S Banerji, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Aleena Banerji
investigator title: MD, Assistant Professor of Medicine
mesh term: Anaphylaxis
mesh term: Shock