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/NCT05982574</url>
    </required_header>
    <id_info>
      <org_study_id>S-515/2013 S-270/2001</org_study_id>
      <nct_id>NCT05982574</nct_id>
    </id_info>
    <brief_title>Tumor Microenvironment</brief_title>
    <official_title>Tumor Microenvironment in Lung Adenocarcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Heidelberg</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital Heidelberg</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>
        Cancer immunotherapy has the great potential to achieve long-term survival in patients with a&#xD;
        solid malignancy. However, the beneficial effect of cancer immunotherapy is seen in only a&#xD;
        minority of patients. Mounting evidence suggests that immunosuppressive features in the tumor&#xD;
        microenvironment prevent an effective antitumor defense. The aim of the investigators is to&#xD;
        comprehensively analyze the cytokine profile and the tumor immune infiltrate in the tumor&#xD;
        microenvironment and to investigate its prognostic significance in patients with radically&#xD;
        resected lung adenocarcinoma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">February 2016</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2024</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Overall survival</measure>
      <time_frame>From date of surgery until the date of death from any cause assessed up to 100 months</time_frame>
      <description>Association of tumor microenvironment with overall survival</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Recurrence-free survival</measure>
      <time_frame>From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
      <description>Association of tumor microenvironment with recurrence-free survival</description>
    </secondary_outcome>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Lung Adenocarcinoma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with completely resected lung adenocarcinoma stage IB and II&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Lung adenocarcinoma&#xD;
  &#xD;
            -  Tumor stage IB and II&#xD;
  &#xD;
            -  With or without adjuvant therapy&#xD;
  &#xD;
            -  Complete surgical resection (R0)&#xD;
  &#xD;
            -  No distant metastasis at the time of surgery (M0)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Second cancer within 5 years&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Seyer Safi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Technical University of Munich</affiliation>
    </overall_official>
    <results_reference>
      <citation>Beck C, Ramanujam D, Vaccarello P, Widenmeyer F, Feuerherd M, Cheng CC, Bomhard A, Abikeeva T, Schadler J, Sperhake JP, Graw M, Safi S, Hoffmann H, Staab-Weijnitz CA, Rad R, Protzer U, Frischmuth T, Engelhardt S. Trimannose-coupled antimiR-21 for macrophage-targeted inhalation treatment of acute inflammatory lung damage. Nat Commun. 2023 Jul 28;14(1):4564. doi: 10.1038/s41467-023-40185-1.</citation>
      <PMID>37507393</PMID>
    </results_reference>
    <results_reference>
      <citation>Safi S, Messner L, Kliebisch M, Eggert L, Ceylangil C, Lennartz P, Jefferies B, Klein H, Schirren M, Dommasch M, Lobinger D, Multhoff G. Circulating Hsp70 Levels and the Immunophenotype of Peripheral Blood Lymphocytes as Potential Biomarkers for Advanced Lung Cancer and Therapy Failure after Surgery. Biomolecules. 2023 May 22;13(5):874. doi: 10.3390/biom13050874.</citation>
      <PMID>37238744</PMID>
    </results_reference>
    <results_reference>
      <citation>Safi S, Yamauchi Y, Hoffmann H, Weichert W, Jost PJ, Winter H, Muley T, Beckhove P. Circulating Interleukin-4 Is Associated with a Systemic T Cell Response against Tumor-Associated Antigens in Treatment-Naive Patients with Resectable Non-Small-Cell Lung Cancer. Cancers (Basel). 2020 Nov 24;12(12):3496. doi: 10.3390/cancers12123496.</citation>
      <PMID>33255425</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital Heidelberg</investigator_affiliation>
      <investigator_full_name>Dr. med. Seyer Safi</investigator_full_name>
      <investigator_title>PD Dr. Seyer Safi</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenocarcinoma</mesh_term>
      <mesh_term>Adenocarcinoma of Lung</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/NCT05982574
  org study id: S-515/2013 S-270/2001
  nct id: NCT05982574
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cancer immunotherapy has the great potential to achieve long-term survival in patients with a
        solid malignancy. However, the beneficial effect of cancer immunotherapy is seen in only a
        minority of patients. Mounting evidence suggests that immunosuppressive features in the tumor
        microenvironment prevent an effective antitumor defense. The aim of the investigators is to
        comprehensively analyze the cytokine profile and the tumor immune infiltrate in the tumor
        microenvironment and to investigate its prognostic significance in patients with radically
        resected lung adenocarcinoma.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Overall survival
  time frame: From date of surgery until the date of death from any cause assessed up to 100 months
  description: Association of tumor microenvironment with overall survival
  measure: Recurrence-free survival
  time frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
  description: Association of tumor microenvironment with recurrence-free survival
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Seyer Safi, MD
  role: Principal Investigator
  affiliation: Technical University of Munich
  citation: Beck C, Ramanujam D, Vaccarello P, Widenmeyer F, Feuerherd M, Cheng CC, Bomhard A, Abikeeva T, Schadler J, Sperhake JP, Graw M, Safi S, Hoffmann H, Staab-Weijnitz CA, Rad R, Protzer U, Frischmuth T, Engelhardt S. Trimannose-coupled antimiR-21 for macrophage-targeted inhalation treatment of acute inflammatory lung damage. Nat Commun. 2023 Jul 28;14(1):4564. doi: 10.1038/s41467-023-40185-1.
  PMID: 37507393
  citation: Safi S, Messner L, Kliebisch M, Eggert L, Ceylangil C, Lennartz P, Jefferies B, Klein H, Schirren M, Dommasch M, Lobinger D, Multhoff G. Circulating Hsp70 Levels and the Immunophenotype of Peripheral Blood Lymphocytes as Potential Biomarkers for Advanced Lung Cancer and Therapy Failure after Surgery. Biomolecules. 2023 May 22;13(5):874. doi: 10.3390/biom13050874.
  PMID: 37238744
  citation: Safi S, Yamauchi Y, Hoffmann H, Weichert W, Jost PJ, Winter H, Muley T, Beckhove P. Circulating Interleukin-4 Is Associated with a Systemic T Cell Response against Tumor-Associated Antigens in Treatment-Naive Patients with Resectable Non-Small-Cell Lung Cancer. Cancers (Basel). 2020 Nov 24;12(12):3496. doi: 10.3390/cancers12123496.
  PMID: 33255425
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital Heidelberg
  investigator full name: Dr. med. Seyer Safi
  investigator title: PD Dr. Seyer Safi
  mesh term: Adenocarcinoma
  mesh term: Adenocarcinoma of Lung