<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/NCT04486820</url>
  </required_header>
  <id_info>
    <org_study_id>20CH028</org_study_id>
    <nct_id>NCT04486820</nct_id>
  </id_info>
  <brief_title>Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care</brief_title>
  <acronym>CHORDOMES</acronym>
  <official_title>Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Chordomas are very rare malignant tumors, chemo-resistant with high propensity for&#xD;
      recurrence. The role of immunotherapy in these patients remains largely unexplored while&#xD;
      PD-L1 and CD8 status in the micro-environment of chordomas is basically not known. Similarly,&#xD;
      this tumor often poses diagnostic difficulties due to its resemblance with metastasis or&#xD;
      chondrosarcoma, thus, it would be useful to know the expression status of factors used during&#xD;
      the work-up of metastatic or mesenchymal tumors, like CDX2, INSM1 and FOXA1, which remains&#xD;
      unknown for chordomas. Thus, the aim of the study is to explore PD-L1, CD8, CDX2, INSM1 and&#xD;
      FOXA1 expression in a series of chordomas and compare it with clinico-pathological and&#xD;
      prognostic features.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retrospective, non-interventional study. A series of chordomas will be analyzed for detailed&#xD;
      histologic features and for various immunohistochemical factors and results will be compared&#xD;
      with clinical factors, like overall and disease-free survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Expression of PD-L1</measure>
    <time_frame>Baseline</time_frame>
    <description>measured by immunohistochemical method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expression of CD8</measure>
    <time_frame>Baseline</time_frame>
    <description>measured by immunohistochemical method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expression of CDX2</measure>
    <time_frame>Baseline</time_frame>
    <description>measured by immunohistochemical method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expression of INSM1</measure>
    <time_frame>Baseline</time_frame>
    <description>measured by immunohistochemical method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expression of FOXA1</measure>
    <time_frame>Baseline</time_frame>
    <description>measured by immunohistochemical method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histological type of tumor</measure>
    <time_frame>Baseline</time_frame>
    <description>data collected in personal health records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor location</measure>
    <time_frame>Baseline</time_frame>
    <description>data collected in personal health records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>survival of patients after diagnosis with or without progression</measure>
    <time_frame>Baseline</time_frame>
    <description>data collected in personal health records.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Chordoma</condition>
  <arm_group>
    <arm_group_label>Chordoma</arm_group_label>
    <description>Patients diagnosed with chordoma</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Analysis Immunohistochemical</intervention_name>
    <description>Analysis of histological material for immunohistochemical study. To explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression</description>
    <arm_group_label>Chordoma</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with chordoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with chordoma&#xD;
&#xD;
          -  Sufficient histological material available&#xD;
&#xD;
          -  Tumor expression of brachyury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Insufficient histological material&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georgia KARPATHIOU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunohistochemical</keyword>
  <keyword>PD-L1</keyword>
  <keyword>CD8</keyword>
  <keyword>CDX2</keyword>
  <keyword>INSM1</keyword>
  <keyword>FOXA1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chordoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04486820
org study id: 20CH028
nct id: NCT04486820
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chordomas are very rare malignant tumors, chemo-resistant with high propensity for
      recurrence. The role of immunotherapy in these patients remains largely unexplored while
      PD-L1 and CD8 status in the micro-environment of chordomas is basically not known. Similarly,
      this tumor often poses diagnostic difficulties due to its resemblance with metastasis or
      chondrosarcoma, thus, it would be useful to know the expression status of factors used during
      the work-up of metastatic or mesenchymal tumors, like CDX2, INSM1 and FOXA1, which remains
      unknown for chordomas. Thus, the aim of the study is to explore PD-L1, CD8, CDX2, INSM1 and
      FOXA1 expression in a series of chordomas and compare it with clinico-pathological and
      prognostic features.
Retrospective, non-interventional study. A series of chordomas will be analyzed for detailed
      histologic features and for various immunohistochemical factors and results will be compared
      with clinical factors, like overall and disease-free survival.
observational model: Cohort
time perspective: Retrospective
measure: Expression of PD-L1
time frame: Baseline
description: measured by immunohistochemical method
measure: Expression of CD8
time frame: Baseline
description: measured by immunohistochemical method
measure: Expression of CDX2
time frame: Baseline
description: measured by immunohistochemical method
measure: Expression of INSM1
time frame: Baseline
description: measured by immunohistochemical method
measure: Expression of FOXA1
time frame: Baseline
description: measured by immunohistochemical method
measure: Histological type of tumor
time frame: Baseline
description: data collected in personal health records.
measure: Tumor location
time frame: Baseline
description: data collected in personal health records.
measure: survival of patients after diagnosis with or without progression
time frame: Baseline
description: data collected in personal health records.
arm group label: Chordoma
description: Patients diagnosed with chordoma
intervention type: Other
intervention name: Analysis Immunohistochemical
description: Analysis of histological material for immunohistochemical study. To explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression
arm group label: Chordoma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Georgia KARPATHIOU, MD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
mesh term: Chordoma
sharing ipd: No