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/NCT06039527</url>
    </required_header>
    <id_info>
      <org_study_id>P21.066</org_study_id>
      <secondary_id>NL77841.058.21</secondary_id>
      <nct_id>NCT06039527</nct_id>
    </id_info>
    <brief_title>TINO: T Cells in the Nose of Older Adults</brief_title>
    <acronym>TINO</acronym>
    <official_title>TINO: Identifying the Underlying Mechanisms and Consequences of the Loss of Nasal T Cells in Vital and Frail Older Individuals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Leiden University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Leiden University Medical Center</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>
        Rationale: Individuals with advanced age are at a progressively increasing risk of acquiring&#xD;
        lower respiratory tract infections. Besides calendar age, the degree of frailty also&#xD;
        associates with increased susceptibility to pneumonia requiring hospitalization. How&#xD;
        alterations in the mucosal immune system with advanced age predispose to infections remains&#xD;
        unclear as access to relevant tissue samples is limited. With minimally-invasive nasal&#xD;
        sampling methods, it was recently observed that in vital older adults, both CD4+ T cells and&#xD;
        CD8+ T cells are selectively lost from the nasal mucosa. However, the exact phenotype,&#xD;
        underlying mechanisms, key molecules and consequences of this have not yet been investigated.&#xD;
  &#xD;
        Objective:&#xD;
  &#xD;
        Elucidate the mechanisms underlying the loss of nasal T cells and characterize in depth the&#xD;
        differences of T cells in young and older adults and associate this loss with susceptibility&#xD;
        to infections.&#xD;
  &#xD;
        Study design: Prospective cohort study&#xD;
  &#xD;
        Study population: Participants will be recruited from 3 groups:&#xD;
  &#xD;
          -  healthy young adults (18-30 years, n=50)&#xD;
  &#xD;
          -  vital older adults (&gt;65 years, n=60)&#xD;
  &#xD;
          -  frail elderly (&gt;65 years, n=60). This group includes individuals without a history of&#xD;
             recurrent respiratory infections or with &gt;2 self-reported episodes of respiratory&#xD;
             infection in the past year.&#xD;
  &#xD;
        Main study parameters/endpoints: Frequency of nasal CD8+ T cells in young adults and frail&#xD;
        older adults.&#xD;
  &#xD;
        Secondary study parameters/endpoints:&#xD;
  &#xD;
          -  Phenotype (subsets, activation status), functionality, transcriptomic state, clonality&#xD;
             and frequency of nasal and blood T cell populations&#xD;
  &#xD;
          -  Stability of T cells and other immune parameters, as described for main study parameter,&#xD;
             during a second sample after 3 months.&#xD;
  &#xD;
          -  Analysis of other immune populations as for main study parameter&#xD;
  &#xD;
          -  Concentration of nasal and systemic factors (e.g. cytokines and metabolites) and their&#xD;
             association with T cells and other immune populations&#xD;
  &#xD;
          -  Respiratory tract microbiota profiles and presence of asymptomatic viral infections and&#xD;
             their association with T cells and other immune parameters&#xD;
  &#xD;
          -  Chronological and biological age, sex, and other immunologically relevant parameters&#xD;
             with T cell populations and other immune parameters&#xD;
  &#xD;
          -  Alteration of T cell phenotype, during and following respiratory tract infections.&#xD;
             Levels of antigen-specific T cells and other immune parameters in nose and blood post&#xD;
             infection.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 24, 2021</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</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>Frequency of nasal CD8+ T cells in young adults and frail older adults.</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>CD8 T cells relative to nasal epithelial cells (ratio)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Phenotype of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>percentage of T cells and T cell subsets</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functionality of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>percentage of T cells responding to in vitro stimulations</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Transcriptomic state of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>T cell clusters based on gene expression patterns</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clonality of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>Number and proportion of TCR clones</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stability of nasal T cells, as described for main study parameter, during a second sample after 3 months.</measure>
      <time_frame>baseline sample versus month 3 sample</time_frame>
      <description>CD8 T cells relative to nasal epithelial cells (ratio)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stability of nasal immune populations, during a second sample after 3 months.</measure>
      <time_frame>baseline sample versus month 3 sample</time_frame>
      <description>immune cell populations relative to nasal epithelial cells (ratio)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of nasal immune cell populations between young adults, vital and frail elderly</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>ratio to epithelial cells</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of peripheral immune cell populations between young adults, vital and frail elderly</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>percentage of total CD45+ cells</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of nasal and systemic factors (e.g. cytokines and metabolites) and their association with T cells and other immune populations</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>concentrations</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory tract microbiota profiles and their association with T cells and other immune parameters</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>microbiota abundance (total sum scaling)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Presence of asymptomatic viral infections and their association with T cells and other immune parameters</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>viral of loads (Ct)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of sex on aging effects of nasal immune populations</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>ratio to nasal epithelial cells</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of sex on aging effects of blood immune populations</measure>
      <time_frame>baseline sample or month 3 sample</time_frame>
      <description>percentage of CD45+ cells</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequencies of antigen-specific T cells in nose post infection.</measure>
      <time_frame>symptom onset and 1, 3 and 5 months later</time_frame>
      <description>antigen-specific T cells as percentage of T cells</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequencies of antigen-specific T cells in blood post infection.</measure>
      <time_frame>symptom onset and 1, 3 and 5 months later</time_frame>
      <description>antigen-specific T cells as percentage of T cells</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">170</enrollment>
    <condition>Respiratory Tract Infections</condition>
    <condition>Aging</condition>
    <arm_group>
      <arm_group_label>Young adults</arm_group_label>
      <description>N=50 of this group No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Vital elderly</arm_group_label>
      <description>N=60 of this group No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Frail elderly</arm_group_label>
      <description>N=60 of this group. Half with recurring respiratory infections, and half without No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset</description>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        We will collect the following samples:&#xD;
  &#xD;
          -  peripheral blood&#xD;
  &#xD;
          -  nasopharyngeal swab&#xD;
  &#xD;
          -  oropharyngeal swab&#xD;
  &#xD;
          -  nasal curettes&#xD;
  &#xD;
          -  nasosorption&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Study population: We will recruit participants from 3 groups:&#xD;
  &#xD;
            -  healthy young adults (18-30 years, n=50)&#xD;
  &#xD;
            -  vital older adults (&gt;65 years, n=60)&#xD;
  &#xD;
            -  frail elderly (&gt;65 years, n=60). These will be consist of individuals without a&#xD;
               history of recurrent respiratory infections or with &gt;2 self-reported episodes of&#xD;
               respiratory infection in the past year.&#xD;
  &#xD;
          Frailty will be determined by a clinical frailty score. The Clinical Frailty Scale (CFS) is&#xD;
          a scale that caretakers can use to identify level of frailty in older patients from 1 (very&#xD;
          fit) through 9 (terminally ill). For the present study, we will define &quot;vital older&#xD;
          patients&quot; as those with a CFS of 1-3 and &quot;older patients living with frailty with a CFS of&#xD;
          4 or higher&quot;.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          In order to be eligible to participate in this study, a subject must meet all of the&#xD;
          following criteria:&#xD;
  &#xD;
          * Adults able and willing to provide informed consent.&#xD;
  &#xD;
          Specific inclusion criteria per group:&#xD;
  &#xD;
          Young adults aged 18-30 Healthy elderly aged &gt;65 Frail elderly &gt;65&#xD;
  &#xD;
          Clinical Frailty score healthy elderly 1-3 Clinical Frailty score frail elderly &gt;3&#xD;
          Self-reported respiratory tract infection in previous year healthy elderly 0-1&#xD;
          Self-reported respiratory tract infection in previous year frail elderly 0-1 or &gt;1&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Incompetence to provide informed consent prior or during study&#xD;
  &#xD;
            -  Current smoker or &gt;40 pack year history&#xD;
  &#xD;
            -  History of severe nose bleedings&#xD;
  &#xD;
            -  Diagnosed with asthma, COPD or chronic rhinosinusitis&#xD;
  &#xD;
            -  Use of inhalation corticosteroids or antibiotics in the past 6 weeks&#xD;
  &#xD;
            -  Current use of anti-coagulants (to prevent nosebleeds). Platelet inhibitors like&#xD;
               acetylsalicylzuur (Ascal) are allowed.&#xD;
  &#xD;
            -  Respiratory tract infection or common cold in the past 2 weeks&#xD;
  &#xD;
            -  Immunocompromised individuals (with primary immune deficiency or secondary immune&#xD;
               deficiency)&#xD;
  &#xD;
            -  Life expectancy &lt;28 days in the opinion of study physician&#xD;
  &#xD;
            -  Vaccination in the 2 months prior to study start A potential subject that is only&#xD;
               excluded from participation based on a recent vaccination will be asked to&#xD;
               re-participate 2 months post vaccination.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Simon P Jochems, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>LUMC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Simon P Jochems, PhD</last_name>
      <phone>+31715261328</phone>
      <email>s.p.jochems@lumc.nl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Leiden University Medical Center</name>
        <address>
          <city>Leiden</city>
          <state>Zuid Holland</state>
          <zip>2333ZA</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Simon P Jochems, PhD</last_name>
        <phone>+31715261328</phone>
        <email>s.p.jochems@lumc.nl</email>
      </contact>
      <investigator>
        <last_name>Geert G Groeneveld, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Simon M Mooijaart, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Leo G Visser, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jutte JC de Vries, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hermelijn H Smits, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
      <investigator_full_name>Simon P Jochems, PhD</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Tract Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>As even pseudonymized data is considered personal data as these can sometimes be traced back to an individual, data can be requested from the PI. If requests fall within the scope of the informed consent and study protocol, an MTA/DTA can be shared. Data will be posted on repositories with restricted access.</ipd_description>
    </patient_data>
    <!-- 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/NCT06039527
  org study id: P21.066
  secondary id: NL77841.058.21
  nct id: NCT06039527
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Rationale: Individuals with advanced age are at a progressively increasing risk of acquiring
        lower respiratory tract infections. Besides calendar age, the degree of frailty also
        associates with increased susceptibility to pneumonia requiring hospitalization. How
        alterations in the mucosal immune system with advanced age predispose to infections remains
        unclear as access to relevant tissue samples is limited. With minimally-invasive nasal
        sampling methods, it was recently observed that in vital older adults, both CD4+ T cells and
        CD8+ T cells are selectively lost from the nasal mucosa. However, the exact phenotype,
        underlying mechanisms, key molecules and consequences of this have not yet been investigated.
  
        Objective:
  
        Elucidate the mechanisms underlying the loss of nasal T cells and characterize in depth the
        differences of T cells in young and older adults and associate this loss with susceptibility
        to infections.
  
        Study design: Prospective cohort study
  
        Study population: Participants will be recruited from 3 groups:
  
          -  healthy young adults (18-30 years, n=50)
  
          -  vital older adults (>65 years, n=60)
  
          -  frail elderly (>65 years, n=60). This group includes individuals without a history of
             recurrent respiratory infections or with >2 self-reported episodes of respiratory
             infection in the past year.
  
        Main study parameters/endpoints: Frequency of nasal CD8+ T cells in young adults and frail
        older adults.
  
        Secondary study parameters/endpoints:
  
          -  Phenotype (subsets, activation status), functionality, transcriptomic state, clonality
             and frequency of nasal and blood T cell populations
  
          -  Stability of T cells and other immune parameters, as described for main study parameter,
             during a second sample after 3 months.
  
          -  Analysis of other immune populations as for main study parameter
  
          -  Concentration of nasal and systemic factors (e.g. cytokines and metabolites) and their
             association with T cells and other immune populations
  
          -  Respiratory tract microbiota profiles and presence of asymptomatic viral infections and
             their association with T cells and other immune parameters
  
          -  Chronological and biological age, sex, and other immunologically relevant parameters
             with T cell populations and other immune parameters
  
          -  Alteration of T cell phenotype, during and following respiratory tract infections.
             Levels of antigen-specific T cells and other immune parameters in nose and blood post
             infection.
  observational model: Cohort
  time perspective: Prospective
  measure: Frequency of nasal CD8+ T cells in young adults and frail older adults.
  time frame: baseline sample or month 3 sample
  description: CD8 T cells relative to nasal epithelial cells (ratio)
  measure: Phenotype of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.
  time frame: baseline sample or month 3 sample
  description: percentage of T cells and T cell subsets
  measure: Functionality of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.
  time frame: baseline sample or month 3 sample
  description: percentage of T cells responding to in vitro stimulations
  measure: Transcriptomic state of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.
  time frame: baseline sample or month 3 sample
  description: T cell clusters based on gene expression patterns
  measure: Clonality of nasal and blood T cell populations in young adults, healthy older adults and frail older adults that suffer from recurrent respiratory tract infections or not.
  time frame: baseline sample or month 3 sample
  description: Number and proportion of TCR clones
  measure: Stability of nasal T cells, as described for main study parameter, during a second sample after 3 months.
  time frame: baseline sample versus month 3 sample
  description: CD8 T cells relative to nasal epithelial cells (ratio)
  measure: Stability of nasal immune populations, during a second sample after 3 months.
  time frame: baseline sample versus month 3 sample
  description: immune cell populations relative to nasal epithelial cells (ratio)
  measure: Comparison of nasal immune cell populations between young adults, vital and frail elderly
  time frame: baseline sample or month 3 sample
  description: ratio to epithelial cells
  measure: Comparison of peripheral immune cell populations between young adults, vital and frail elderly
  time frame: baseline sample or month 3 sample
  description: percentage of total CD45+ cells
  measure: Concentration of nasal and systemic factors (e.g. cytokines and metabolites) and their association with T cells and other immune populations
  time frame: baseline sample or month 3 sample
  description: concentrations
  measure: Respiratory tract microbiota profiles and their association with T cells and other immune parameters
  time frame: baseline sample or month 3 sample
  description: microbiota abundance (total sum scaling)
  measure: Presence of asymptomatic viral infections and their association with T cells and other immune parameters
  time frame: baseline sample or month 3 sample
  description: viral of loads (Ct)
  measure: Effect of sex on aging effects of nasal immune populations
  time frame: baseline sample or month 3 sample
  description: ratio to nasal epithelial cells
  measure: Effect of sex on aging effects of blood immune populations
  time frame: baseline sample or month 3 sample
  description: percentage of CD45+ cells
  measure: Frequencies of antigen-specific T cells in nose post infection.
  time frame: symptom onset and 1, 3 and 5 months later
  description: antigen-specific T cells as percentage of T cells
  measure: Frequencies of antigen-specific T cells in blood post infection.
  time frame: symptom onset and 1, 3 and 5 months later
  description: antigen-specific T cells as percentage of T cells
  arm group label: Young adults
  description: N=50 of this group No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset
  arm group label: Vital elderly
  description: N=60 of this group No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset
  arm group label: Frail elderly
  description: N=60 of this group. Half with recurring respiratory infections, and half without No intervention. Sampling at timepoint 0 and for 50% of the group another sample at 3 months If respiratory symptoms develop in the 3 months after timepoint 0, participants are invited to provide a NPS/OPS to identify causative agent, and if one is established, individuals are sampled 3 more times at months 1, 3 and 5 post symptom onset
  We will collect the following samples:
  
          -  peripheral blood
  
          -  nasopharyngeal swab
  
          -  oropharyngeal swab
  
          -  nasal curettes
  
          -  nasosorption
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Simon P Jochems, PhD
  role: Principal Investigator
  affiliation: LUMC
  last name: Simon P Jochems, PhD
  phone: +31715261328
  email: s.p.jochems@lumc.nl
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Leiden University Medical Center
  investigator full name: Simon P Jochems, PhD
  investigator title: Assistant professor
  mesh term: Respiratory Tract Infections
  sharing ipd: No
  ipd description: As even pseudonymized data is considered personal data as these can sometimes be traced back to an individual, data can be requested from the PI. If requests fall within the scope of the informed consent and study protocol, an MTA/DTA can be shared. Data will be posted on repositories with restricted access.