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/NCT06024226</url>
    </required_header>
    <id_info>
      <org_study_id>CHUBX 2023/35</org_study_id>
      <nct_id>NCT06024226</nct_id>
    </id_info>
    <brief_title>Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC</brief_title>
    <acronym>MyéloLungSC</acronym>
    <official_title>Role of Myeloid Derived Suppressive Cells (MDSCs) and Cancer Stem Cells and Their Cross Talks in Non-Small Cell Lung Cancer (NSCLC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Bordeaux</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Bordeaux</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>
        Immunotherapy have revolutionized the field of oncology, but response rates are low and all&#xD;
        patients relapse, due to cellular and soluble immunosuppressive mechanisms. MDSC are one of&#xD;
        the most important immunosuppressive cells, that also harbour non immunologic functions,&#xD;
        favouring cancer invasion. We want to better characterize these non immunologic functions of&#xD;
        MDSC in lung cancer. Indeed, we will analyse cellular mechanisms by in vitro studies,&#xD;
        assessing the effect of immunosuppressive cells, provided by fresh tumor samples, on&#xD;
        phenotype and functions of lung cancer cell lines. The aim of this study is to better&#xD;
        characterize immunosuppressive landscape of NSCLC and mechanisms involved in their protumor&#xD;
        functions&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In recent years, immune-based therapies have revolutionized the field of oncology by&#xD;
        significantly improving survival of cancer patients. Despite sustained responses, only 20% to&#xD;
        40% of cancer patients respond. It has become clear that the immunosuppressive environment&#xD;
        induced by tumor through cellular and/or soluble pathways critically contribute to hinder&#xD;
        efficient antitumor immunity. The inhibition of these immunosuppressive networks thus&#xD;
        represents an essential prerequisite for the improvement of responses to anticancer&#xD;
        immunotherapies. Several immune cell populations have been identified as key actors of&#xD;
        tumor-induced immunosuppression, among which are myeloid-derived suppressor cells (MDSC) and&#xD;
        regulatory T lymphocytes (Treg). However, in non-small cell lung cancers (NSCLC), the&#xD;
        prognostic role of these cells, the mechanisms underlying their immunosuppressive functions,&#xD;
        their &quot;non-immunological&quot; protumoral functions and their role in dampening the efficacy of&#xD;
        immunotherapies in clinical practice are less characterized. The aim of this project is to&#xD;
        better characterize the non immunologic functions of MDSC. We propose to assess in vitro the&#xD;
        non-immunological pro-tumor functions of MDSC isolated from lung cancer patients&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>Comparative analysis of the modifications of phenotype and functions of lung cancer cell lines when exposed to MDSC extracted from patient tumor tissue</measure>
      <time_frame>At the time of surgery only, when fresh tumor is resected</time_frame>
      <description>Functional in vitro studies of the effect of MDSC extracted from resected NSCLC prospectively collected on phenotype and function of lung cancer cell lines</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Lung Neoplasms</condition>
    <condition>Myeloid-Derived Suppressor Cells</condition>
    <condition>Immunosuppression</condition>
    <arm_group>
      <arm_group_label>Patients with lung carcinoma surgically treated by surgery only</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Tumor samples</intervention_name>
      <description>Tumor samples will be collected by the pathologist at the reception of the tumor removed during surgery</description>
      <arm_group_label>Patients with lung carcinoma surgically treated by surgery only</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with lung carcinoma surgically treated by surgery only&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  consecutive patients&#xD;
  &#xD;
            -  lung carcinoma surgically treated by surgery only&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patient receiving chemotherapy, radiotherapy or immunotherapy in the neoadjuvant&#xD;
               setting (all objectives)&#xD;
  &#xD;
            -  patient with concomitant or previous cancer (in the 2 years)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Charlotte DOMBLIDES</last_name>
      <email>charlotte.domblides@chu-bordeaux.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Matthieu THUMEREL</last_name>
      <email>matthieu.thumerel@chu-bordeaux.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU de Bordeaux - Hôpital Saint-André, Service d'Oncologie Médicale</name>
        <address>
          <city>Bordeaux</city>
          <zip>33000</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Charlotte DOMBLIDES</last_name>
        <email>charlotte.domblides@chu-bordeaux.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lung cancer</keyword>
    <keyword>Immunosuppression</keyword>
    <keyword>Immuno-oncology</keyword>
    <keyword>Antitumor immune escape</keyword>
    <keyword>Invasion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06024226
  org study id: CHUBX 2023/35
  nct id: NCT06024226
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Immunotherapy have revolutionized the field of oncology, but response rates are low and all
        patients relapse, due to cellular and soluble immunosuppressive mechanisms. MDSC are one of
        the most important immunosuppressive cells, that also harbour non immunologic functions,
        favouring cancer invasion. We want to better characterize these non immunologic functions of
        MDSC in lung cancer. Indeed, we will analyse cellular mechanisms by in vitro studies,
        assessing the effect of immunosuppressive cells, provided by fresh tumor samples, on
        phenotype and functions of lung cancer cell lines. The aim of this study is to better
        characterize immunosuppressive landscape of NSCLC and mechanisms involved in their protumor
        functions
  In recent years, immune-based therapies have revolutionized the field of oncology by
        significantly improving survival of cancer patients. Despite sustained responses, only 20% to
        40% of cancer patients respond. It has become clear that the immunosuppressive environment
        induced by tumor through cellular and/or soluble pathways critically contribute to hinder
        efficient antitumor immunity. The inhibition of these immunosuppressive networks thus
        represents an essential prerequisite for the improvement of responses to anticancer
        immunotherapies. Several immune cell populations have been identified as key actors of
        tumor-induced immunosuppression, among which are myeloid-derived suppressor cells (MDSC) and
        regulatory T lymphocytes (Treg). However, in non-small cell lung cancers (NSCLC), the
        prognostic role of these cells, the mechanisms underlying their immunosuppressive functions,
        their "non-immunological" protumoral functions and their role in dampening the efficacy of
        immunotherapies in clinical practice are less characterized. The aim of this project is to
        better characterize the non immunologic functions of MDSC. We propose to assess in vitro the
        non-immunological pro-tumor functions of MDSC isolated from lung cancer patients
  observational model: Cohort
  time perspective: Prospective
  measure: Comparative analysis of the modifications of phenotype and functions of lung cancer cell lines when exposed to MDSC extracted from patient tumor tissue
  time frame: At the time of surgery only, when fresh tumor is resected
  description: Functional in vitro studies of the effect of MDSC extracted from resected NSCLC prospectively collected on phenotype and function of lung cancer cell lines
  arm group label: Patients with lung carcinoma surgically treated by surgery only
  intervention type: Procedure
  intervention name: Tumor samples
  description: Tumor samples will be collected by the pathologist at the reception of the tumor removed during surgery
  arm group label: Patients with lung carcinoma surgically treated by surgery only
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Charlotte DOMBLIDES
  email: charlotte.domblides@chu-bordeaux.fr
  last name: Matthieu THUMEREL
  email: matthieu.thumerel@chu-bordeaux.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  sharing ipd: No