<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/NCT01666275</url>
  </required_header>
  <id_info>
    <org_study_id>2012P000448</org_study_id>
    <nct_id>NCT01666275</nct_id>
  </id_info>
  <brief_title>The Metabolomics of Anaphylaxis</brief_title>
  <official_title>The Metabolomics of Anaphylaxis</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>
      Metabolomics is the study of metabolic pathways and the unique biochemical molecules which&#xD;
      result from the regulatory response to physiological stressors, disease processes, or drug&#xD;
      therapy. By measuring changes in metabolite concentrations, the range of biochemical effects&#xD;
      and therapeutic intervention can be determined.&#xD;
&#xD;
      Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease&#xD;
      characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to&#xD;
      aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin&#xD;
      during challenge/desensitization is equivalent to an allergic drug reaction however we are&#xD;
      able to evaluate these specific reactions in a controlled, clinical environment. This&#xD;
      population of patients undergoing aspirin desensitization is ideal for studying metabolomics&#xD;
      as serial blood sampling can be performed in patients before, during a reaction, and after&#xD;
      aspirin desensitization, thereby allowing each patient to serve as his or her own biological&#xD;
      control. The investigator hopes that this study of metabolomics will allow for better methods&#xD;
      of identifying anaphylaxis in the future.&#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Withdrawn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>March 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 Baseline to 1 week post-desensitization</measure>
    <time_frame>before start of aspirin desensitization, 2 hours into desensitization, at time of reaction(s) - an expected average of 6 hours into desensitization, 1 week post-desensitization</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>Patients With AERD Undergoing Aspirin Desensitization</condition>
  <arm_group>
    <arm_group_label>Aspirin desensitization</arm_group_label>
    <description>This group of patients has AERD (aspirin exacerbated respiratory disease) and is undergoing aspirin desensitization.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      We retain and freeze the plasma from blood after spinning down whole-blood samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients ages 18-75, history of an allergic reaction to aspirin and referred for a&#xD;
        clinically indicated outpatient or inpatient aspirin desensitization procedure for aspirin&#xD;
        exacerbated respiratory disease (AERD)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ages 18-75 with a history of aspirin anaphylaxis or a history of&#xD;
             hypersensitivity reaction to aspirin and referred for a clinically indicated&#xD;
             outpatient or inpatient aspirin desensitization procedure for AERD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy/breastfeeding, possibility of poor compliance, unwilling to undergo aspirin&#xD;
             desensitization.&#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>
  </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/NCT01666275
org study id: 2012P000448
nct id: NCT01666275
lead sponsor: 
has dmc: No
Metabolomics is the study of metabolic pathways and the unique biochemical molecules which
      result from the regulatory response to physiological stressors, disease processes, or drug
      therapy. By measuring changes in metabolite concentrations, the range of biochemical effects
      and therapeutic intervention can be determined.

      Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease
      characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to
      aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin
      during challenge/desensitization is equivalent to an allergic drug reaction however we are
      able to evaluate these specific reactions in a controlled, clinical environment. This
      population of patients undergoing aspirin desensitization is ideal for studying metabolomics
      as serial blood sampling can be performed in patients before, during a reaction, and after
      aspirin desensitization, thereby allowing each patient to serve as his or her own biological
      control. The investigator hopes that this study of metabolomics will allow for better methods
      of identifying anaphylaxis in the future.
observational model: Case-Only
time perspective: Prospective
measure: Change in metabolic profile of blood serum metabolites from Baseline to 1 week post-desensitization
time frame: before start of aspirin desensitization, 2 hours into desensitization, at time of reaction(s) - an expected average of 6 hours into desensitization, 1 week post-desensitization
description: Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes.
arm group label: Aspirin desensitization
description: This group of patients has AERD (aspirin exacerbated respiratory disease) and is undergoing aspirin desensitization.
We retain and freeze the plasma from blood after spinning down whole-blood samples.
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