<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/NCT02192866</url>
  </required_header>
  <id_info>
    <org_study_id>13-2102</org_study_id>
    <secondary_id>UL1TR001082</secondary_id>
    <nct_id>NCT02192866</nct_id>
  </id_info>
  <brief_title>Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies</brief_title>
  <official_title>Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Food allergies are now a major problem. These experiments involve getting blood from people&#xD;
      with food allergies and from people without food allergies. The blood collected will be used&#xD;
      to answer questions and find information about peanut and other food allergies.&#xD;
&#xD;
      Samples will come from:&#xD;
&#xD;
        -  People signed up by the investigators at the University of Colorado Denver&#xD;
&#xD;
        -  University of North Carolina, Massachusetts General Hospital, Children's Hospital of&#xD;
           Colorado and the Immune Tolerance Network (Benaroya Research Institute) where people&#xD;
           have been treated for peanut allergies&#xD;
&#xD;
        -  University of North Carolina, Massachusetts General Hospital, National Jewish Health and&#xD;
           The Children's Hospital in Denver where people have taken part or will take part in&#xD;
           clinically indicated oral food challenges.&#xD;
&#xD;
      Blood and health histories from the University of North Carolina, Massachusetts General&#xD;
      Hospital, National Jewish Health, The Children's Hospital and the Immune Tolerance Network&#xD;
      will not have personal information linked.&#xD;
&#xD;
      The specific aims of this experiment are:&#xD;
&#xD;
        1. Come up with a lab test that will predict how bad an allergic reaction will be to&#xD;
           peanuts.&#xD;
&#xD;
        2. Find out what part of a peanut causes allergic reactions.&#xD;
&#xD;
        3. Come up with preventions that can block peanut allergies.&#xD;
&#xD;
        4. Find the strongest proteins in walnuts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overview: This is a protocol for obtaining serum, plasma, and cells from subjects with&#xD;
      specific food allergies and from controls to be used in studies of peanut and other&#xD;
      allergens. We are only asking the CTRC for help with drawing blood, separating serum,&#xD;
      labeling tubes and to aliquot the serum. In addition, we will receive de-identified serum and&#xD;
      plasma from other institutions and de-identified cord blood from the University of Colorado&#xD;
      Denver Cord Blood bank.&#xD;
&#xD;
      The previous version of this application was COMIRB protocol 09-0813. This was last updated&#xD;
      03-03-2016. Much of the work outlined in protocol 09-0813 was completed and a manuscript is&#xD;
      under review. This protocol is still only for the purpose of drawing blood and obtaining&#xD;
      clinical histories. As such the risks and benefits in the informed consent have not changed.&#xD;
&#xD;
      Based on new NIH funding (RO3 AI 164349; started 7-09-21) and RO1-AI165866 (9th %-tile;&#xD;
      scheduled to begin 09-01-21), the project now includes 5 specific aims (Aims #1-5). Aims 1 &amp;&#xD;
      2 are part of an R21 funded project (R21 AI135397; 11/16/2018-10/31/2020; extended until&#xD;
      10/31/2021 without additional funds) to Dr. Dreskin. Aims 3 &amp; 4 are part of an R21 funded&#xD;
      project (R21 AI137881; 11/28/2018-10/31/2020; extended until 10/31/2021 without additional&#xD;
      funds) to Dr. Chen (Dr. Dreskin is Co-PI). These proposals are highly complementary and each&#xD;
      only needs access to blood samples. Dr. Dreskin's proposal consists of in vitro experiments&#xD;
      to test IgE binding to novel peptides. Dr. Chen's proposal uses human serum or plasma as a&#xD;
      source of IgE with which to identify and characterize mimotopes for murine studies. Aim 5 is&#xD;
      an exploratory aim to obtain preliminary data for an RO1 to be submitted in 2019. For all of&#xD;
      these projects, the only experiments that involve human materials are ex vivo assays of&#xD;
      basophil activation, in vitro assays of IgE binding and generation of humanized mice using&#xD;
      de-identified cord blood that will otherwise be discarded. There are no therapeutic&#xD;
      interventions for human subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">December 2030</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify which traits are associated with severe food allergy.</measure>
    <time_frame>1 day of single blood draw</time_frame>
    <description>This is an observational study, to describe traits (identified through blood tests) associated with severe food allergy, particularly peanut allergy.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Peanut Allergies</condition>
  <condition>Tree Nut Allergies</condition>
  <condition>Other Food Allergies</condition>
  <arm_group>
    <arm_group_label>Peanut allergic</arm_group_label>
    <description>No intervention(s) to be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other food allergic</arm_group_label>
    <description>No intervention(s) to be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>No intervention(s) to be administered.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults and children who are allergic to peanuts and/or tree-nuts and individuals with no&#xD;
        known food allergies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        This protocol is to draw blood for a variety of related studies of food allergy. For this&#xD;
        reason, we will list each group of subjects and the inclusion criteria for that group.&#xD;
&#xD;
          1. De-identified sera or plasma from patients who have undergone Oral ImmunoTherapy (OIT)&#xD;
             for peanut allergy. These samples already exist.&#xD;
&#xD;
               -  Inclusion criteria:&#xD;
&#xD;
                    1. patients have been enrolled in a controlled trial of OIT for peanuts, and&#xD;
                       had at least one oral challenge.&#xD;
&#xD;
                    2. Age 1-75.&#xD;
&#xD;
          2. De-identified samples from patients who are undergoing clinically indicated food&#xD;
             challenges for peanut allergy.&#xD;
&#xD;
               -  Inclusion criteria:&#xD;
&#xD;
                    1. concern regarding possible allergy to peanuts,&#xD;
&#xD;
                    2. age 1-75,&#xD;
&#xD;
                    3. plan to undergo a clinically indicated challenge with peanuts.&#xD;
&#xD;
          3. Patients with peanut allergy.&#xD;
&#xD;
               -  Inclusion criteria:&#xD;
&#xD;
                    1. excellent history of a systemic reaction to peanuts,&#xD;
&#xD;
                    2. age 6-75.&#xD;
&#xD;
          4. Patients with other food allergies (especially tree nuts).&#xD;
&#xD;
               -  Inclusion criteria:&#xD;
&#xD;
                    1. excellent history of a systemic reaction to tree nuts or other foods,&#xD;
&#xD;
                    2. age 6-75.&#xD;
&#xD;
          5. Normal controls.&#xD;
&#xD;
               -  Inclusion criteria:&#xD;
&#xD;
                    1. no known food allergies,&#xD;
&#xD;
                    2. recent ingestion of peanuts without difficulty, and&#xD;
&#xD;
                    3. age 6-75.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any known significant medical or psychiatric diagnosis&#xD;
&#xD;
          2. Use of an investigational drug within 30 days&#xD;
&#xD;
          3. Use of omalizumab (anti-IgE; Xolair) within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Dreskin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephen Dreskin, MD, PhD</last_name>
    <phone>303-724-7190</phone>
    <email>Stephen.Dreskin@ucdenver.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Colorado School of Medicine</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen C Dreskin</last_name>
      <phone>303-877-2754</phone>
      <email>stephen.dreskin@cuanschutz.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Dreskin SC, Koppelman SJ, Andorf S, Nadeau KC, Kalra A, Braun W, Negi SS, Chen X, Schein CH. The importance of the 2S albumins for allergenicity and cross-reactivity of peanuts, tree nuts, and sesame seeds. J Allergy Clin Immunol. 2021 Apr;147(4):1154-1163. doi: 10.1016/j.jaci.2020.11.004. Epub 2020 Nov 18.</citation>
    <PMID>33217410</PMID>
  </results_reference>
  <results_reference>
    <citation>Hazebrouck S, Patil SU, Guillon B, Lahood N, Dreskin SC, Adel-Patient K, Bernard H. Immunodominant conformational and linear IgE epitopes lie in a single segment of Ara h 2. J Allergy Clin Immunol. 2022 Jul;150(1):131-139. doi: 10.1016/j.jaci.2021.12.796. Epub 2022 Feb 10.</citation>
    <PMID>35150723</PMID>
  </results_reference>
  <results_reference>
    <citation>Hazebrouck S, Canon N, Dreskin SC. The Effector Function of Allergens. Front Allergy. 2022 Feb 7;3:818732. doi: 10.3389/falgy.2022.818732. eCollection 2022.</citation>
    <PMID>35386644</PMID>
  </results_reference>
  <results_reference>
    <citation>Dreskin SC, Germinaro M, Reinhold D, Chen X, Vickery BP, Kulis M, Burks AW, Negi SS, Braun W, Chambliss JM, Eglite S, McNulty CMG. IgE binding to linear epitopes of Ara h 2 in peanut allergic preschool children undergoing oral Immunotherapy. Pediatr Allergy Immunol. 2019 Dec;30(8):817-823. doi: 10.1111/pai.13117. Epub 2019 Oct 21.</citation>
    <PMID>31437325</PMID>
  </results_reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>February 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>December 14, 2022</last_update_submitted>
  <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
    <mesh_term>Peanut Hypersensitivity</mesh_term>
    <mesh_term>Nut Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02192866
org study id: 13-2102
secondary id: UL1TR001082
nct id: NCT02192866
lead sponsor: 
collaborator: 
has dmc: Yes
Food allergies are now a major problem. These experiments involve getting blood from people
      with food allergies and from people without food allergies. The blood collected will be used
      to answer questions and find information about peanut and other food allergies.

      Samples will come from:

        -  People signed up by the investigators at the University of Colorado Denver

        -  University of North Carolina, Massachusetts General Hospital, Children's Hospital of
           Colorado and the Immune Tolerance Network (Benaroya Research Institute) where people
           have been treated for peanut allergies

        -  University of North Carolina, Massachusetts General Hospital, National Jewish Health and
           The Children's Hospital in Denver where people have taken part or will take part in
           clinically indicated oral food challenges.

      Blood and health histories from the University of North Carolina, Massachusetts General
      Hospital, National Jewish Health, The Children's Hospital and the Immune Tolerance Network
      will not have personal information linked.

      The specific aims of this experiment are:

        1. Come up with a lab test that will predict how bad an allergic reaction will be to
           peanuts.

        2. Find out what part of a peanut causes allergic reactions.

        3. Come up with preventions that can block peanut allergies.

        4. Find the strongest proteins in walnuts.
Overview: This is a protocol for obtaining serum, plasma, and cells from subjects with
      specific food allergies and from controls to be used in studies of peanut and other
      allergens. We are only asking the CTRC for help with drawing blood, separating serum,
      labeling tubes and to aliquot the serum. In addition, we will receive de-identified serum and
      plasma from other institutions and de-identified cord blood from the University of Colorado
      Denver Cord Blood bank.

      The previous version of this application was COMIRB protocol 09-0813. This was last updated
      03-03-2016. Much of the work outlined in protocol 09-0813 was completed and a manuscript is
      under review. This protocol is still only for the purpose of drawing blood and obtaining
      clinical histories. As such the risks and benefits in the informed consent have not changed.

      Based on new NIH funding (RO3 AI 164349; started 7-09-21) and RO1-AI165866 (9th %-tile;
      scheduled to begin 09-01-21), the project now includes 5 specific aims (Aims #1-5). Aims 1 &
      2 are part of an R21 funded project (R21 AI135397; 11/16/2018-10/31/2020; extended until
      10/31/2021 without additional funds) to Dr. Dreskin. Aims 3 & 4 are part of an R21 funded
      project (R21 AI137881; 11/28/2018-10/31/2020; extended until 10/31/2021 without additional
      funds) to Dr. Chen (Dr. Dreskin is Co-PI). These proposals are highly complementary and each
      only needs access to blood samples. Dr. Dreskin's proposal consists of in vitro experiments
      to test IgE binding to novel peptides. Dr. Chen's proposal uses human serum or plasma as a
      source of IgE with which to identify and characterize mimotopes for murine studies. Aim 5 is
      an exploratory aim to obtain preliminary data for an RO1 to be submitted in 2019. For all of
      these projects, the only experiments that involve human materials are ex vivo assays of
      basophil activation, in vitro assays of IgE binding and generation of humanized mice using
      de-identified cord blood that will otherwise be discarded. There are no therapeutic
      interventions for human subjects.
observational model: Case-Control
time perspective: Other
measure: Identify which traits are associated with severe food allergy.
time frame: 1 day of single blood draw
description: This is an observational study, to describe traits (identified through blood tests) associated with severe food allergy, particularly peanut allergy.
arm group label: Peanut allergic
description: No intervention(s) to be administered.
arm group label: Other food allergic
description: No intervention(s) to be administered.
arm group label: Controls
description: No intervention(s) to be administered.
Blood samples.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Dreskin, MD, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Stephen Dreskin, MD, PhD
phone: 303-724-7190
email: Stephen.Dreskin@ucdenver.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Dreskin SC, Koppelman SJ, Andorf S, Nadeau KC, Kalra A, Braun W, Negi SS, Chen X, Schein CH. The importance of the 2S albumins for allergenicity and cross-reactivity of peanuts, tree nuts, and sesame seeds. J Allergy Clin Immunol. 2021 Apr;147(4):1154-1163. doi: 10.1016/j.jaci.2020.11.004. Epub 2020 Nov 18.
PMID: 33217410
citation: Hazebrouck S, Patil SU, Guillon B, Lahood N, Dreskin SC, Adel-Patient K, Bernard H. Immunodominant conformational and linear IgE epitopes lie in a single segment of Ara h 2. J Allergy Clin Immunol. 2022 Jul;150(1):131-139. doi: 10.1016/j.jaci.2021.12.796. Epub 2022 Feb 10.
PMID: 35150723
citation: Hazebrouck S, Canon N, Dreskin SC. The Effector Function of Allergens. Front Allergy. 2022 Feb 7;3:818732. doi: 10.3389/falgy.2022.818732. eCollection 2022.
PMID: 35386644
citation: Dreskin SC, Germinaro M, Reinhold D, Chen X, Vickery BP, Kulis M, Burks AW, Negi SS, Braun W, Chambliss JM, Eglite S, McNulty CMG. IgE binding to linear epitopes of Ara h 2 in peanut allergic preschool children undergoing oral Immunotherapy. Pediatr Allergy Immunol. 2019 Dec;30(8):817-823. doi: 10.1111/pai.13117. Epub 2019 Oct 21.
PMID: 31437325
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity
mesh term: Peanut Hypersensitivity
mesh term: Nut Hypersensitivity
sharing ipd: No