<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/NCT03819829</url>
  </required_header>
  <id_info>
    <org_study_id>B18HIR</org_study_id>
    <nct_id>NCT03819829</nct_id>
  </id_info>
  <brief_title>Blood Sampling of Healthy Volunteers for Immunological Research</brief_title>
  <official_title>Blood Sampling of Healthy Volunteers for Immunological Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Netherlands Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Netherlands Cancer Institute</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 protocol will be used to collect crucial components of the immune system from healthy&#xD;
      volunteers for the characterization of immune cells in fresh blood. A pipeline has been set&#xD;
      up for comprehensive immune phenotyping of both lymphoid and myeloid cells within 24 hours&#xD;
      after blood withdrawal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to properly compare the immunobiology of healthy volunteers to (advanced) cancer&#xD;
      patients, the investigators use age-matched controls with no history of cancer and no&#xD;
      potentially interfering medication.&#xD;
&#xD;
      Healthy volunteers will be asked to donate 5 tubes of blood&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Anticipated">December 2, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 2, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of immune cells, both lymphoid and myeloid, present in the blood of healthy individuals, assessed by flow cytometry, as well as cytokine expression and transcriptome profiles of these cells</measure>
    <time_frame>assessed up to 12 months</time_frame>
    <description>the number of lymphoid and myeloid immune cells present in the blood of healthy individuals using flow cytometry, assessing the cytokine expression of these cells in healthy individuals using ELISA cytokine assays, and assessing gene expression of these cells using single cell transcriptomics analyses using droplet-based single cell RNA sequencing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunophenotyping of both myeloid and lymphoid cells in healthy individuals</measure>
    <time_frame>assessed up to 12 months</time_frame>
    <description>Immunophenotyping of both myeloid and lymphoid cells in healthy controls to gain insights in immunological defects and immune evasion in cancer patients</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Blood sample</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Blood sample</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Blood sample</description>
    <arm_group_label>Blood sample</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 35 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  No history of cancer&#xD;
&#xD;
          -  No use of systemic immunosuppressive medication (eg. corticosteroids). Local use of&#xD;
             corticosteroids (eg. topical or inhalation) is allowed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fever 14 days before blood withdrawal&#xD;
&#xD;
          -  Donated blood for the same program within the last 2 years&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>36 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>M Kok, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NKI-AvL</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>M Kok, MD</last_name>
    <phone>3120512</phone>
    <phone_ext>9111</phone_ext>
    <email>m.kok@nki.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>L Voorwerk, MD</last_name>
    <phone>3120512</phone>
    <phone_ext>9111</phone_ext>
    <email>l.voorwerk@nki.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NKI-AVL</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>M Kok, MD</last_name>
      <email>m.kok@nki.nl</email>
    </contact>
    <contact_backup>
      <last_name>L Voorwerk, MD</last_name>
      <email>l.voorwerk@nki.nl</email>
    </contact_backup>
    <investigator>
      <last_name>M Kok, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>to be determined</ipd_description>
  </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/NCT03819829
org study id: B18HIR
nct id: NCT03819829
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This protocol will be used to collect crucial components of the immune system from healthy
      volunteers for the characterization of immune cells in fresh blood. A pipeline has been set
      up for comprehensive immune phenotyping of both lymphoid and myeloid cells within 24 hours
      after blood withdrawal.
In order to properly compare the immunobiology of healthy volunteers to (advanced) cancer
      patients, the investigators use age-matched controls with no history of cancer and no
      potentially interfering medication.

      Healthy volunteers will be asked to donate 5 tubes of blood
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The number of immune cells, both lymphoid and myeloid, present in the blood of healthy individuals, assessed by flow cytometry, as well as cytokine expression and transcriptome profiles of these cells
time frame: assessed up to 12 months
description: the number of lymphoid and myeloid immune cells present in the blood of healthy individuals using flow cytometry, assessing the cytokine expression of these cells in healthy individuals using ELISA cytokine assays, and assessing gene expression of these cells using single cell transcriptomics analyses using droplet-based single cell RNA sequencing.
measure: Immunophenotyping of both myeloid and lymphoid cells in healthy individuals
time frame: assessed up to 12 months
description: Immunophenotyping of both myeloid and lymphoid cells in healthy controls to gain insights in immunological defects and immune evasion in cancer patients
arm group label: Blood sample
arm group type: Other
description: Blood sample
intervention type: Other
intervention name: Blood sample
description: Blood sample
arm group label: Blood sample
criteria: 
gender: All
minimum age: 36 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: M Kok, MD
role: Principal Investigator
affiliation: NKI-AvL
last name: M Kok, MD
phone: 3120512
phone ext: 9111
email: m.kok@nki.nl
last name: L Voorwerk, MD
phone: 3120512
phone ext: 9111
email: l.voorwerk@nki.nl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: to be determined