<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/NCT03234764</url>
  </required_header>
  <id_info>
    <org_study_id>36616</org_study_id>
    <nct_id>NCT03234764</nct_id>
  </id_info>
  <brief_title>Longitudinal Follow-up Study for Food Allergies</brief_title>
  <official_title>Longitudinal Follow-up Study for Food Allergies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the clinical usefulness of assessing specific human&#xD;
      allergy antibodies and other immunologic parameters associated with the diagnosis, evolution,&#xD;
      and management of allergic disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to strengthen our ability to understand the long-term effects of&#xD;
      food immunotherapy on the immune system and how it may induce tolerance to foods that&#xD;
      participants were once allergic to. Investigators hope to determine tools and immunologic&#xD;
      parameters that can help predict sustained desensitization and tolerance to food allergens&#xD;
      following food immunotherapy. By evaluating the in-depth characteristics of allergy antibody&#xD;
      populations and other immunologic parameters and comparing them to clinical disease, the&#xD;
      investigators may uncover a more sound way to diagnose, follow and treat food allergic&#xD;
      disease over time. Investigators will follow up with participants who underwent immunotherapy&#xD;
      to food allergens as volunteers in clinical trials at the Sean N. Parker Center and assess&#xD;
      whether they experience sustained desensitization to these foods in the long-term.&#xD;
      Investigators will investigate the properties of the participants' immune cells and how they&#xD;
      are affected over time by the ingestion of these food allergens. Investigators will follow&#xD;
      the significance of different dosing regimens in terms of achieving tolerance. Differences in&#xD;
      immune cell characteristics and other biological parameters may help predict the nature of a&#xD;
      participant's tolerance to the food allergens and may help in the development of tools to&#xD;
      determine permanent tolerance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">December 18, 2017</completion_date>
  <primary_completion_date type="Actual">December 18, 2017</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>Immunological markers</measure>
    <time_frame>February 2027</time_frame>
    <description>IgE, IgG4, T cells</description>
  </primary_outcome>
  <enrollment type="Actual">166</enrollment>
  <condition>Food Allergy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Immunotherapy</intervention_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Sputum Buccal swab Saliva Urine Stool&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants who underwent immunotherapy in clinical trial at the Sean N. Parker Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ages 6 months through 70 years who have previously undergone a food&#xD;
             immunotherapy protocol only at our center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None. However, if a participant becomes pregnant, their clinic visit may be postponed&#xD;
             until after delivery and/or lactation period. These subject can postpone visits for&#xD;
             one year and choose to skip visits during pregnancy and another year after (if&#xD;
             breastfeeding).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab. Allergy Asthma Clin Immunol. 2017 Dec 21;13:51. doi: 10.1186/s13223-017-0223-8. eCollection 2017.</citation>
    <PMID>29296107</PMID>
  </reference>
  <reference>
    <citation>Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Feasibility of sustained response through long-term dosing in food allergy immunotherapy. Allergy Asthma Clin Immunol. 2017 Dec 21;13:52. doi: 10.1186/s13223-017-0224-7. eCollection 2017.</citation>
    <PMID>29296108</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>February 14, 2018</last_update_submitted>
  <last_update_submitted_qc>February 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Sharon Chinthrajah</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>IgE</keyword>
  <keyword>Allergy</keyword>
  <keyword>Tolerance</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Desensitization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunomodulating Agents</mesh_term>
  </intervention_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/NCT03234764
org study id: 36616
nct id: NCT03234764
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the clinical usefulness of assessing specific human
      allergy antibodies and other immunologic parameters associated with the diagnosis, evolution,
      and management of allergic disease.
The purpose of this study is to strengthen our ability to understand the long-term effects of
      food immunotherapy on the immune system and how it may induce tolerance to foods that
      participants were once allergic to. Investigators hope to determine tools and immunologic
      parameters that can help predict sustained desensitization and tolerance to food allergens
      following food immunotherapy. By evaluating the in-depth characteristics of allergy antibody
      populations and other immunologic parameters and comparing them to clinical disease, the
      investigators may uncover a more sound way to diagnose, follow and treat food allergic
      disease over time. Investigators will follow up with participants who underwent immunotherapy
      to food allergens as volunteers in clinical trials at the Sean N. Parker Center and assess
      whether they experience sustained desensitization to these foods in the long-term.
      Investigators will investigate the properties of the participants' immune cells and how they
      are affected over time by the ingestion of these food allergens. Investigators will follow
      the significance of different dosing regimens in terms of achieving tolerance. Differences in
      immune cell characteristics and other biological parameters may help predict the nature of a
      participant's tolerance to the food allergens and may help in the development of tools to
      determine permanent tolerance.
observational model: Cohort
time perspective: Prospective
measure: Immunological markers
time frame: February 2027
description: IgE, IgG4, T cells
intervention type: Other
intervention name: Immunotherapy
Blood Sputum Buccal swab Saliva Urine Stool
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 70 Years
healthy volunteers: No
citation: Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab. Allergy Asthma Clin Immunol. 2017 Dec 21;13:51. doi: 10.1186/s13223-017-0223-8. eCollection 2017.
PMID: 29296107
citation: Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Feasibility of sustained response through long-term dosing in food allergy immunotherapy. Allergy Asthma Clin Immunol. 2017 Dec 21;13:52. doi: 10.1186/s13223-017-0224-7. eCollection 2017.
PMID: 29296108
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Sharon Chinthrajah
investigator title: Clinical Assistant Professor
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity
mesh term: Immunomodulating Agents