xml: <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/NCT06037967</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/23/0173</org_study_id>
      <nct_id>NCT06037967</nct_id>
    </id_info>
    <brief_title>Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders</brief_title>
    <acronym>BIRD-A</acronym>
    <official_title>Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Toulouse</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 study aims to build up a clinico-biological bank of samples from patients suspected of&#xD;
        or suffering from allergic diseases (including asthma) or mast cell diseases in order to&#xD;
        support future research in the field of allergic diseases. The biobank will help to identify&#xD;
        new prognostic, diagnostic and/or predictive biomarkers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective monocentric collection of biological samples combined with clinical and&#xD;
        paraclinical data from patients suffering from allergic diseases, asthma or mast cell&#xD;
        disorders. The aim of this collection is to collect biological samples and clinical data to&#xD;
        be used for various exploratory, diagnostic and/or prospective and/or predictive studies.&#xD;
  &#xD;
        The samples and data will be pseudonymised, i.e. identified by the first letter of the&#xD;
        patient's surname and first name and by a number allocated in chronological order of patient&#xD;
        inclusion, and will be stored in a bank. The samples and data making up this&#xD;
        clinico-biological bank will be used for subsequent exploratory work used as a priority to&#xD;
        answer questions from the Toulouse University Hospital teams in the field of allergic&#xD;
        diseases, asthma and/or mast cell disorders, in accordance with the information given to the&#xD;
        patient. They may also be transferred to specialised research teams as part of national or&#xD;
        international collaborations, or sold to academic or industrial partners. These transfers as&#xD;
        part of collaborations or assignments will be legally governed by contracts guaranteeing&#xD;
        compliance with the RGPD, where applicable, and the use of these samples in accordance with&#xD;
        current legislation and the information provided to patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2038</completion_date>
    <primary_completion_date type="Anticipated">May 2038</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>Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders</measure>
      <time_frame>15 years</time_frame>
      <description>constitution of a clinico-biological biobanking</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>set of diagnostic and/or prognostic biomarkers</measure>
      <time_frame>15 years</time_frame>
      <description>identify new set of diagnostic and/or prognostic biomarkers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>set of predictive biomarkers</measure>
      <time_frame>15 years</time_frame>
      <description>Identify new biomarkers and/or a set of predictive biomarkers of the severity of the pathology or the response to treatments.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Allergy markers exploration</measure>
      <time_frame>15 years</time_frame>
      <description>Explore if allergy markers (including asthma) or mastocytosis can be found in samples other than blood (urine, skin, etc.).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimation of concordance of biomarkers</measure>
      <time_frame>15 years</time_frame>
      <description>Estimate the concordance of the presence of known and/or newly identified biomarkers of interest in the biological sample(s) making up the clinical-biological bank with the clinical data collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of biomarkers</measure>
      <time_frame>15 years</time_frame>
      <description>Study the evolution over time of the biomarkers of interest and/or newly identified in the biological sample(s) constituting the clinical-biological bank.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exploration of biological mechanisms</measure>
      <time_frame>15 years</time_frame>
      <description>Explore through molecular and/or genomic and/or transcriptomic and/or proteomic studies the biological mechanisms specific to patients with allergic (including asthma) or mast cell pathologies to improve screening, diagnosis, orientation treatment and/or knowledge and understanding of these pathologies</description>
    </secondary_outcome>
    <enrollment type="Anticipated">3200</enrollment>
    <condition>Allergic Diseases</condition>
    <condition>Asthma</condition>
    <condition>Mast Cell Disorders</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        blood sample and tumor tissues&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          patients with respiratory disease or allergic disease or mast cell disorders&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with a positive prick test or specific IgE regardless of the allergen&#xD;
  &#xD;
            -  patients suspected of allergic pathology defined by the need to carry out a prick test&#xD;
               or specific IgE or a food or drug reintroduction test as part of the treatment&#xD;
  &#xD;
            -  patients with systemic or cutaneous mastocytosis according to the international&#xD;
               classification8&#xD;
  &#xD;
            -  patients with mast cell activation syndrome according to the international&#xD;
               classification8&#xD;
  &#xD;
            -  patients with familial hyper-alpha tryptasemia on the presence of variation in the&#xD;
               number of copies of the alpha allele of the TPSAB1 gene&#xD;
  &#xD;
            -  patients with asthma of any severity&#xD;
  &#xD;
            -  adults (aged 18 and over)&#xD;
  &#xD;
            -  people affiliated or beneficiaries of a social security scheme&#xD;
  &#xD;
            -  patients able to receive and understand the information on the study and their&#xD;
               participation and having freely consented to it in writing before any collection of&#xD;
               samples or data necessary for the research (no restriction of rights by the judicial&#xD;
               authorities and mastery of the French language).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients under legal protection, guardianship or curatorship&#xD;
  &#xD;
            -  pregnant or breastfeeding women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Laurent GUILLEMINAULT, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Toulouse</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laurent GUILLEMINAULT, MD</last_name>
      <phone>05 67 77 17 51</phone>
      <email>guilleminault.l@chu-toulouse.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Laurent GUILLEMINAULT</name>
        <address>
          <city>Toulouse</city>
          <zip>31059</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Laurent GUILLEMINAULT, MD</last_name>
        <phone>05 67 77 17 51</phone>
        <email>guilleminault@chu-toulouse.fr</email>
      </contact>
      <investigator>
        <last_name>Cristina LIVIDEAU, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Allergy</keyword>
    <keyword>asthma</keyword>
    <keyword>mast cell disorders</keyword>
    <keyword>biomarkers</keyword>
    <keyword>biobank</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Tract Diseases</mesh_term>
      <mesh_term>Respiration Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037967
  org study id: RC31/23/0173
  nct id: NCT06037967
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to build up a clinico-biological bank of samples from patients suspected of
        or suffering from allergic diseases (including asthma) or mast cell diseases in order to
        support future research in the field of allergic diseases. The biobank will help to identify
        new prognostic, diagnostic and/or predictive biomarkers.
  This is a prospective monocentric collection of biological samples combined with clinical and
        paraclinical data from patients suffering from allergic diseases, asthma or mast cell
        disorders. The aim of this collection is to collect biological samples and clinical data to
        be used for various exploratory, diagnostic and/or prospective and/or predictive studies.
  
        The samples and data will be pseudonymised, i.e. identified by the first letter of the
        patient's surname and first name and by a number allocated in chronological order of patient
        inclusion, and will be stored in a bank. The samples and data making up this
        clinico-biological bank will be used for subsequent exploratory work used as a priority to
        answer questions from the Toulouse University Hospital teams in the field of allergic
        diseases, asthma and/or mast cell disorders, in accordance with the information given to the
        patient. They may also be transferred to specialised research teams as part of national or
        international collaborations, or sold to academic or industrial partners. These transfers as
        part of collaborations or assignments will be legally governed by contracts guaranteeing
        compliance with the RGPD, where applicable, and the use of these samples in accordance with
        current legislation and the information provided to patients.
  observational model: Cohort
  time perspective: Prospective
  measure: Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders
  time frame: 15 years
  description: constitution of a clinico-biological biobanking
  measure: set of diagnostic and/or prognostic biomarkers
  time frame: 15 years
  description: identify new set of diagnostic and/or prognostic biomarkers
  measure: set of predictive biomarkers
  time frame: 15 years
  description: Identify new biomarkers and/or a set of predictive biomarkers of the severity of the pathology or the response to treatments.
  measure: Allergy markers exploration
  time frame: 15 years
  description: Explore if allergy markers (including asthma) or mastocytosis can be found in samples other than blood (urine, skin, etc.).
  measure: Estimation of concordance of biomarkers
  time frame: 15 years
  description: Estimate the concordance of the presence of known and/or newly identified biomarkers of interest in the biological sample(s) making up the clinical-biological bank with the clinical data collected.
  measure: Evolution of biomarkers
  time frame: 15 years
  description: Study the evolution over time of the biomarkers of interest and/or newly identified in the biological sample(s) constituting the clinical-biological bank.
  measure: Exploration of biological mechanisms
  time frame: 15 years
  description: Explore through molecular and/or genomic and/or transcriptomic and/or proteomic studies the biological mechanisms specific to patients with allergic (including asthma) or mast cell pathologies to improve screening, diagnosis, orientation treatment and/or knowledge and understanding of these pathologies
  blood sample and tumor tissues
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Laurent GUILLEMINAULT, MD
  role: Principal Investigator
  affiliation: University Hospital, Toulouse
  last name: Laurent GUILLEMINAULT, MD
  phone: 05 67 77 17 51
  email: guilleminault.l@chu-toulouse.fr
  facility: 
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Respiratory Tract Diseases
  mesh term: Respiration Disorders