<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/NCT02194530</url>
  </required_header>
  <id_info>
    <org_study_id>1405015102</org_study_id>
    <nct_id>NCT02194530</nct_id>
  </id_info>
  <brief_title>Reduction of Peanut Reactivity and Immune Modulation With Anti-IgE Therapy</brief_title>
  <official_title>Pilot Study to Collect Blood From Research Subjects Allergic and Non-allergic to Peanut to Study Immune Modulation With Anti-IgE Therapy in Mice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study is will examine the pathways involved in allergic response, primarily in&#xD;
      food allergy; specifically peanut allergy. We will also study non-allergic donors as well as&#xD;
      patients with atopic disorders, primarily as control subjects. We believe that this study&#xD;
      will lead to discovery of significant pathways involved in the allergic pathway that can be&#xD;
      explored in more detail during follow-up studies in order to address mechanistic questions&#xD;
      that cannot be answered in a pilot trial. We believe that such a pilot study represents the&#xD;
      ideal approach to identify effective therapeutic interventions and to simultaneously better&#xD;
      understand the underlying mechanistic properties involved in the allergy cascade. We think&#xD;
      that this study forms the basis for a novel avenue of research into the pathogenesis of&#xD;
      allergic pathways, a disease that is still associated with significant morbidity and&#xD;
      mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to characterize the pathways involved in the allergic response, primarily in&#xD;
      food allergy; specifically peanut allergy. We will also study non-allergic donors as well as&#xD;
      patients with atopic disorders, primarily as control subjects. All eligible study&#xD;
      participants will have documented elevated total IgE levels, peanut positivity or another&#xD;
      antigen/allergen specific elevated IgE (ie common indoor/outdoor allergens) prior to being&#xD;
      enrolled in the study. Our study will focus on allergic as well as non-allergic individuals.&#xD;
      We plan on collecting samples from a total of 60 patients during one time point (peanut&#xD;
      allergic individuals, non-atopic/allergic individuals, atopic individuals-other than peanut&#xD;
      allergy). We believe that such a pilot study represents the ideal approach to identify&#xD;
      effective therapeutic interventions and to simultaneously better understand the underlying&#xD;
      mechanistic properties involved in the allergy cascade. We plan to obtain a detailed history&#xD;
      prior to enrollment as well as objective data (ie SPT as well as Immunocap testing results).&#xD;
      There will be 3 study groups and studies will be performed on approximately 20 peanut&#xD;
      allergic patients, 20 non-allergic controls, and 20 allergic/atopic (non-peanut allergic, but&#xD;
      allergic to indoor/outdoor allergen) individuals. There will be one blood draw required at&#xD;
      each visit (weeks 0, 4, 8). Each blood draw will require 105 ml of whole blood to be&#xD;
      collected in ten heparinized 10-mL tubes and one EDTA tube. We plan to assess the levels of&#xD;
      total IgE and IgG as well as antigen specific IgG and IgE in the peripheral blood of&#xD;
      patients. We will specifically perform ELISA testing that detects these levels. We will also&#xD;
      perform in vitro CD4+ T cell proliferation assays. For this purpose, patients' peripheral T&#xD;
      cells will be isolated with a combination of magnetic beads and flow cytometric sorting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 30, 2015</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Blood test to determine peanut allergy and peanut specific IgE and IgG</measure>
    <time_frame>1 year</time_frame>
    <description>There will be one blood draw at each visit (weeks 0, 4, 8). Each blood draw will require 105 mL of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube. We plan to assess the levels of total IgE and IgG as well as antigen specific IgG and IgE in the peripheral blood of patients. We will specifically perform ELISA testing that detects these levels. We will also perform in vitro CD4+ T cell proliferation assays.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Peanut Allergy</condition>
  <arm_group>
    <arm_group_label>Peanut allergic individuals</arm_group_label>
    <description>20 individuals will be recruited for this group. Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Allergic/atopic individuals (not peanut)</arm_group_label>
    <description>Subjects should not be allergic to peanut. 20 individuals will be recruited for this group. Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-allergic individuals</arm_group_label>
    <description>20 individuals will be recruited for this group. Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        New York Metropolitan area residents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Groups 1-3:&#xD;
&#xD;
        Group 1: Peanut allergic individuals (n=20)&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  Positive ImmunoCAP test (Optional)&#xD;
&#xD;
          -  Documented elevated total IgE levels, peanut positivity or another antigen/allergen&#xD;
             specific elevated IgE (ie common indoor/outdoor allergens)&#xD;
&#xD;
          -  Experienced at least one of the following symptoms within 60 minutes of exposure:&#xD;
&#xD;
               -  Skin-related symptom (i.e., hives and edema)&#xD;
&#xD;
               -  Respiratory-related symptom (i.e., wheezing, throat tightness, repetitive&#xD;
                  coughing, and dyspnea)&#xD;
&#xD;
               -  Gastrointestinal-related symptom (i.e., vomiting and diarrhea)&#xD;
&#xD;
        Group 2: Allergic/atopic individuals (not allergic to peanut; n=20)&#xD;
&#xD;
          -  18-65 years of age.&#xD;
&#xD;
          -  Positive ImmunoCAP test (Optional)&#xD;
&#xD;
          -  Documented elevated total IgE levels or an indoor/outdoor antigen/allergen (other than&#xD;
             peanut) specific elevated IgE (ie common indoor/outdoor allergens).&#xD;
&#xD;
          -  Experienced at least one of the following symptoms within 60 minutes of exposure:&#xD;
&#xD;
               -  Skin-related symptom (i.e., hives and edema).&#xD;
&#xD;
               -  Respiratory-related symptom (i.e., wheezing, throat tightness, repetitive&#xD;
                  coughing, and dyspnea).&#xD;
&#xD;
               -  Gastrointestinal-related symptom (i.e., vomiting and diarrhea)&#xD;
&#xD;
        Group 3: Non-allergic individuals (healthy controls; n=20)&#xD;
&#xD;
          -  18-65 years of age.&#xD;
&#xD;
          -  Negative ImmunoCAP test (Optional)&#xD;
&#xD;
          -  Documented absence or low total IgE levels, or negativity for an antigen/allergen&#xD;
             specific elevated IgE (ie common indoor/outdoor allergens).&#xD;
&#xD;
          -  Has not experienced at least one of the following symptoms within 60 minutes of&#xD;
             exposure to a particular substance:&#xD;
&#xD;
               -  Skin-related symptom (i.e., hives and edema).&#xD;
&#xD;
               -  Respiratory-related symptom (i.e., wheezing, throat tightness, repetitive&#xD;
                  coughing, and dyspnea).&#xD;
&#xD;
               -  Gastrointestinal-related symptom (i.e., vomiting and diarrhea)&#xD;
&#xD;
        Exclusion Criteria for Groups 1-3:&#xD;
&#xD;
          -  Prior therapy with anti-IgE&#xD;
&#xD;
          -  Steroid use greater than 10 mg/d prednisone or equivalent 30 days prior to enrollment&#xD;
&#xD;
          -  Any immunosuppressive drug use within 3 months prior to screening (mycophenolate&#xD;
             mofetil, hydroxychloroquine, azathioprine, methotrexate, leflunomide, rituximab,&#xD;
             cyclophosphamide, intravenous immunoglobulin, plasmapheresis)&#xD;
&#xD;
          -  Ongoing chronic infection (viral, bacterial or fungal) including known HIV, Hepatitis&#xD;
             B/C&#xD;
&#xD;
          -  Acute infection receiving any antibiotics within 30 days prior to screening&#xD;
&#xD;
          -  Probiotics (greater than estimated 109 cfu or organisms per day) within 30 days prior&#xD;
             to enrollment (with the exception of fermented beverages, milks or yogurts).&#xD;
&#xD;
          -  Malignancy within one year prior to screening (with the exception of non-metastatic&#xD;
             squamous or basal cell skin carcinomas and cervical carcinoma if received curative&#xD;
             surgical treatment)&#xD;
&#xD;
          -  Known illicit drug or alcohol abuse&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald G Crystal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Cornell Medical College, NY</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mei Wang, CCRP</last_name>
    <phone>646-962-4590</phone>
    <email>mew2001@med.cornell.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Genetic Medicine, Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mei Wang, CCRP</last_name>
      <phone>646-962-4590</phone>
      <email>mew2001@med.cornell.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Peanut allergic individuals</keyword>
  <keyword>Allergic/atopic individuals (not allergic to peanut)</keyword>
  <keyword>Non-allergic individuals</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peanut 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/NCT02194530
org study id: 1405015102
nct id: NCT02194530
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study is will examine the pathways involved in allergic response, primarily in
      food allergy; specifically peanut allergy. We will also study non-allergic donors as well as
      patients with atopic disorders, primarily as control subjects. We believe that this study
      will lead to discovery of significant pathways involved in the allergic pathway that can be
      explored in more detail during follow-up studies in order to address mechanistic questions
      that cannot be answered in a pilot trial. We believe that such a pilot study represents the
      ideal approach to identify effective therapeutic interventions and to simultaneously better
      understand the underlying mechanistic properties involved in the allergy cascade. We think
      that this study forms the basis for a novel avenue of research into the pathogenesis of
      allergic pathways, a disease that is still associated with significant morbidity and
      mortality.
The study aims to characterize the pathways involved in the allergic response, primarily in
      food allergy; specifically peanut allergy. We will also study non-allergic donors as well as
      patients with atopic disorders, primarily as control subjects. All eligible study
      participants will have documented elevated total IgE levels, peanut positivity or another
      antigen/allergen specific elevated IgE (ie common indoor/outdoor allergens) prior to being
      enrolled in the study. Our study will focus on allergic as well as non-allergic individuals.
      We plan on collecting samples from a total of 60 patients during one time point (peanut
      allergic individuals, non-atopic/allergic individuals, atopic individuals-other than peanut
      allergy). We believe that such a pilot study represents the ideal approach to identify
      effective therapeutic interventions and to simultaneously better understand the underlying
      mechanistic properties involved in the allergy cascade. We plan to obtain a detailed history
      prior to enrollment as well as objective data (ie SPT as well as Immunocap testing results).
      There will be 3 study groups and studies will be performed on approximately 20 peanut
      allergic patients, 20 non-allergic controls, and 20 allergic/atopic (non-peanut allergic, but
      allergic to indoor/outdoor allergen) individuals. There will be one blood draw required at
      each visit (weeks 0, 4, 8). Each blood draw will require 105 ml of whole blood to be
      collected in ten heparinized 10-mL tubes and one EDTA tube. We plan to assess the levels of
      total IgE and IgG as well as antigen specific IgG and IgE in the peripheral blood of
      patients. We will specifically perform ELISA testing that detects these levels. We will also
      perform in vitro CD4+ T cell proliferation assays. For this purpose, patients' peripheral T
      cells will be isolated with a combination of magnetic beads and flow cytometric sorting.
observational model: Case-Control
time perspective: Prospective
measure: Blood test to determine peanut allergy and peanut specific IgE and IgG
time frame: 1 year
description: There will be one blood draw at each visit (weeks 0, 4, 8). Each blood draw will require 105 mL of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube. We plan to assess the levels of total IgE and IgG as well as antigen specific IgG and IgE in the peripheral blood of patients. We will specifically perform ELISA testing that detects these levels. We will also perform in vitro CD4+ T cell proliferation assays.
arm group label: Peanut allergic individuals
description: 20 individuals will be recruited for this group. Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.
arm group label: Allergic/atopic individuals (not peanut)
description: Subjects should not be allergic to peanut. 20 individuals will be recruited for this group. Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.
arm group label: Non-allergic individuals
description: 20 individuals will be recruited for this group. Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.
Whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ronald G Crystal, MD
role: Principal Investigator
affiliation: Weill Cornell Medical College, NY
last name: Mei Wang, CCRP
phone: 646-962-4590
email: mew2001@med.cornell.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Peanut Hypersensitivity
sharing ipd: Undecided