<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/NCT01660776</url>
  </required_header>
  <id_info>
    <org_study_id>2011-A01163-38</org_study_id>
    <secondary_id>B111181-40</secondary_id>
    <secondary_id>11/32-821</secondary_id>
    <nct_id>NCT01660776</nct_id>
  </id_info>
  <brief_title>BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology</brief_title>
  <acronym>BMS_PD-L1</acronym>
  <official_title>BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Research Agency, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diffuse large B-cell lymphomas (DLBCLs) represent 25 to 30% of adult non-Hodgkin lymphomas in&#xD;
      western countries. DLBCLs are aggressive cancer but potentially curable with multi-agent&#xD;
      chemotherapy. Whereas R-CHOP regimen has led to a marked improvement in survival, this&#xD;
      disease remains a biologically heterogeneous entity. New therapeutic strategies are required&#xD;
      including identification of patients' subgroups with different prognostic.&#xD;
&#xD;
      This project is based on BMS_LyTrans and Goelams 075 clinical trial. A study of whole blood&#xD;
      transcriptome in 75 DLBCL patients and in 87 controls showed that PD-L1 (CD274) gene was&#xD;
      overexpressed in DLBCL patients. Preliminary results demonstrated that PD-L1 is detected in&#xD;
      plasma of DLBCL patients with a significantly higher concentration than in controls. This&#xD;
      protein was selected as a potential biomarker because of its established role in anti-tumoral&#xD;
      immunity. Interaction between PD-L1 and its receptor PD-1 is known to inhibit activation of&#xD;
      immune responses by inducing T-lymphocytes anergy and/or apoptosis. Moreover, a direct&#xD;
      involvement of PD-L1 in the protection of cancer cells from lysis by activated T lymphocytes&#xD;
      has been demonstrated. PD-L1 expression has been described in several solid tumours,&#xD;
      including ovary cancer, breast cancer, colon cancer, renal cell carcinoma, non-small cell&#xD;
      lung carcinoma and in hematological malignancies such as T-NHL, MM and Hodgkin's lymphoma.&#xD;
      Furthermore the expression of PD-L1 by tumour cells is associated with poor prognosis. The&#xD;
      blockade of PD-L1/PD-1 axis may represent a novel therapeutic approach in aggressive cancers.&#xD;
      These first results incite to identify the cells releasing soluble PD-L1 and to investigate&#xD;
      its role in the anti-tumoral immunity in DLBCL patients.&#xD;
&#xD;
      The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at&#xD;
      diagnosis in comparison to others tumours known to express PD-L1 (metastatic breast cancer,&#xD;
      Hodgkin's lymphoma, non-small cell lung cancer).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Secondary purposes are :&#xD;
&#xD;
        -  To confirm the presence of plasma soluble form of PD-L1 in others malignancies&#xD;
&#xD;
        -  To study surface expression of PD-L1 on circulating tumour cells with multiparameter fow&#xD;
           cytometry and Veridex® technology in DLBCL and metastatic breast cancer patients&#xD;
&#xD;
        -  To study surface expression of PD-L1 on circulating endothelial cells in DLBCL, Hodgkin&#xD;
           lymphoma and metastatic breast cancer patients (subpart ended in late 2012)&#xD;
&#xD;
        -  To study surface expression of PD-L1 on different types of leukocytes (monocytes, B and&#xD;
           T lymphocytes)&#xD;
&#xD;
        -  To separate circulating tumour cells expressing PD-L1 by immunomagnetic or Cell-sorting&#xD;
           method&#xD;
&#xD;
        -  To develop ELISPOT technique to study the release of soluble PD-L1 in culture&#xD;
           supernatants of selected cells (subpart ended mid 2013)&#xD;
&#xD;
        -  to evaluate the correlation between the expression of PD-L1 in the plasma and *) the&#xD;
           expression of PD-L1 in the tumor, **) the expression of PD-L1 and other molecules in the&#xD;
           bronchoalveolar liquid (whenever available from routine) in non-small cell lung cancer&#xD;
&#xD;
        -  to evaluate the response to treatment according to plasma PD-L1 expression in non-small&#xD;
           cell lung cancer&#xD;
&#xD;
        -  to evaluate the susceptibility to develop a disease according to the single nucleotide&#xD;
           polymorphisms of the PD-L1 gene in DLBCL and non-small cell lung cancer&#xD;
&#xD;
        -  Constitution of the different cohorts and collection of samples Main cohort : de novo&#xD;
           DLBCL at diagnosis Secondary cohorts: Hodgkin's lymphoma, metastatic breast cancer, non&#xD;
           small cell lung cancer Control cohorts : healthy volunteers (blood donors), patients&#xD;
           with immune thrombocytopenia (ITP)&#xD;
&#xD;
        -  Quantification of plasma soluble PD-L1 in the different cohorts&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 7, 2012</start_date>
  <completion_date type="Actual">October 2, 2019</completion_date>
  <primary_completion_date type="Actual">October 2, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Description of one or several blood cell types producing soluble PD-L1 in DLBCL, metastatic breast cancer, Hodgkin's lymphoma and non-small cell lung cancer</measure>
    <time_frame>4 years</time_frame>
    <description>Description of one or several blood cell types producing soluble PD-L1 in DLBCL, metastatic breast cancer, Hodgkin's lymphoma and non-small cell lung cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis of PD-L1 membrane protein expression on circulating tumor cells by multiparameter flow cytometry and Veridex® in DLBCL and metastatic breast cancer, and bone marrow tumor cells by flow cytometry in DLBCL</measure>
    <time_frame>4 years</time_frame>
    <description>Analysis of PD-L1 membrane protein expression on circulating tumor cells by multiparameter flow cytometry and Veridex® in DLBCL and metastatic breast cancer, and bone marrow tumor cells by flow cytometry in DLBCL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of PD-L1 membrane protein expression on circulating endothelial cells with the Veridex® technology in DLBCL, Hodgkin's lymphoma and metastatic breast cancer (subpart ended in late 2012)</measure>
    <time_frame>4 years</time_frame>
    <description>Analysis of PD-L1 membrane protein expression on circulating endothelial cells with the Veridex® technology in DLBCL, Hodgkin's lymphoma and metastatic breast cancer (subpart ended in late 2012)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of PD-L1 membrane protein expression on monocytes, B and T lymphocytes in all cohorts</measure>
    <time_frame>4 years</time_frame>
    <description>Analysis of PD-L1 membrane protein expression on monocytes, B and T lymphocytes in all cohorts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of an ELISPOT technique to detect soluble PD-L1 in the supernatants of sorted primary cells (subpart ended mid 2013)</measure>
    <time_frame>4 years</time_frame>
    <description>Development of an ELISPOT technique to detect soluble PD-L1 in the supernatants of sorted primary cells (subpart ended mid 2013)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the techniques (by immunomagnetic or cell-sorting) used to separate circulating tumor cells expressing PD-L1</measure>
    <time_frame>4 years</time_frame>
    <description>Evaluation of the techniques (by immunomagnetic or cell-sorting) used to separate circulating tumor cells expressing PD-L1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the PD-L1 expression *) in the plasma, **) in the tumor and ***) in the bronchoalveolar liquid in non-small cell lung cancer</measure>
    <time_frame>4 years</time_frame>
    <description>Correlation between the PD-L1 expression *) in the plasma, **) in the tumor and ***) in the bronchoalveolar liquid in non-small cell lung cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the response to treatment according to soluble PD-L1 expression in non-small cell lung cancer</measure>
    <time_frame>4 years</time_frame>
    <description>Evaluation of the response to treatment according to soluble PD-L1 expression in non-small cell lung cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the susceptibility to develop a disease according to PD-L1 gene SNP in DLBCL and non-small cell lung cancer</measure>
    <time_frame>4 years</time_frame>
    <description>Evaluation of the susceptibility to develop a disease according to PD-L1 gene SNP in DLBCL and non-small cell lung cancer</description>
  </secondary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Actual">105</enrollment>
  <condition>Diffuse Large B-cell Lymphoma</condition>
  <condition>Hodgkin Lymphoma</condition>
  <condition>Metastatic Breastcancer</condition>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>DLBCL (diffuse large B-cell lymphoma)</arm_group_label>
    <description>DLBCL (diffuse large B-cell lymphoma)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hodgkin's lymphoma</arm_group_label>
    <description>Hodgkin's lymphoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>metastatic breast cancer</arm_group_label>
    <description>metastatic breast cancer or with lymph node involvement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>immune thrombocytopenia (ITP)</arm_group_label>
    <description>immune thrombocytopenia (ITP)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
    <description>healthy volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-small cell lung cancer</arm_group_label>
    <description>non-small cell lung cancer</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biomedical research on total blood at diagnosis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Number of DLBCL patients : 40 Number of non-small cell lung cancer patients : 100 Number of&#xD;
        Hodgkin patients : 20 Number of metastatic breast cancer patients : 20 Number of healthy&#xD;
        volunteers : 140 Number of patients with immune thrombocytopenia (ITP) : 5&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        General inclusion criteria :&#xD;
&#xD;
          -  Age ≥ 18 years and ≤ 75 years,&#xD;
&#xD;
          -  Life expectancy more than 4 months&#xD;
&#xD;
          -  Signed informed consent obtained&#xD;
&#xD;
          -  Social security affiliation is mandatory&#xD;
&#xD;
          -  Non previously treated (even by corticotherapy),&#xD;
&#xD;
          -  HIV negative, HBs negative, HCV negative&#xD;
&#xD;
        Inclusion criteria for DLBCL patients :&#xD;
&#xD;
          -  A biopsy proven diagnosis of de novo DLBCL according to the current WHO criteria,&#xD;
&#xD;
          -  Immunohistochemistry for GCB/nonGC classification according to Hans' algorithm&#xD;
&#xD;
          -  Patients with advanced-stage disease defined as Ann Arbor stages III or IV, or stages&#xD;
             I or II with bulky disease (&gt;7cm)&#xD;
&#xD;
        Inclusion criteria for non-small cell lung cancer patients :&#xD;
&#xD;
          -  A biopsy proven diagnosis of de novo non-small cell lung cancer (all stages) according&#xD;
             to the current WHO criteria&#xD;
&#xD;
        Inclusion criteria for Hodgkin's lymphoma patients :&#xD;
&#xD;
          -  A biopsy proven diagnosis of Hodgkin's lymphoma according to the current WHO criteria&#xD;
&#xD;
        Inclusion criteria for metastatic breast cancer or with lymph node involvement :&#xD;
&#xD;
          -  A biopsy proven diagnosis infiltrating lobular or ductal breast carcinoma&#xD;
&#xD;
          -  with lymph node involvement or metastasis&#xD;
&#xD;
        Inclusion criteria for patients with immune thrombocytopenia (ITP) :&#xD;
&#xD;
          -  Primary ITP was defined by the IWG as a platelet count less than 100 G/L in the&#xD;
             absence of other causes or disorders that may be associated with thrombocytopenia.&#xD;
&#xD;
          -  Bone marrow examination excluding a central aetiology of thrombocytopenia&#xD;
&#xD;
        Inclusion criteria for healthy volunteers :&#xD;
&#xD;
        - Inclusion criteria for blood donation according to the Etablissement Français du Sang&#xD;
        (EFS) criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General non-inclusion criteria :&#xD;
&#xD;
          -  Age &lt; 18 years et &gt; 75 years,&#xD;
&#xD;
          -  Pregnant women,&#xD;
&#xD;
          -  Person legally involved in a case&#xD;
&#xD;
          -  No social security affiliation&#xD;
&#xD;
          -  Signed informed consent not obtained,&#xD;
&#xD;
          -  Preliminary treatment (even corticoid treatment).&#xD;
&#xD;
          -  HIV positive, HBs positive, HCV positive&#xD;
&#xD;
        Non-inclusion criteria for DLBCL patients :&#xD;
&#xD;
          -  Lymphoma other than DLBCL,&#xD;
&#xD;
          -  Transformation of a low grade lymphoma to a high grade lymphoma (DLBCL),&#xD;
&#xD;
          -  Extranodal marginal zone lymphoma of MALT lymphoma,&#xD;
&#xD;
          -  Post-transplant lymphoproliferative disorders,&#xD;
&#xD;
          -  Lymphoblastic lymphoma,&#xD;
&#xD;
          -  Burkitt's lymphoma,&#xD;
&#xD;
          -  Carcinoma or history of carcinoma except in situ cervical carcinoma.&#xD;
&#xD;
        Non-inclusion criteria for non-small cell lung cancer patients : None&#xD;
&#xD;
        Non-inclusion criteria for Hodgkin patients :&#xD;
&#xD;
        - Non Hodgkin's lymphoma&#xD;
&#xD;
        Non-inclusion criteria for metastatic breast cancer or with lymph node involvement :&#xD;
&#xD;
          -  Carcinoma other than infiltrating lobular or ductal breast carcinoma&#xD;
&#xD;
          -  Chemotherapy in 30 days preceding the inclusion&#xD;
&#xD;
          -  Hormonotherapy in 7 days preceding the inclusion&#xD;
&#xD;
          -  Carcinoma or history of carcinoma except in situ cervical carcinoma.&#xD;
&#xD;
          -  Hemoglobin level &lt; 10g/dl&#xD;
&#xD;
        Non-inclusion criteria for patients with immune thrombocytopenia (ITP) :&#xD;
&#xD;
        - Central aetiology of the thrombocytopenia&#xD;
&#xD;
        Non-inclusion criteria for healthy volunteers :&#xD;
&#xD;
        - Exclusion criteria for blood donation according to the Etablissement Français du Sang&#xD;
        (EFS) criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thierry Fest, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rennes EFS</name>
      <address>
        <city>Rennes</city>
        <state>Brittanny</state>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <state>Brittanny</state>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmette</name>
      <address>
        <city>Marseille</city>
        <zip>13000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>November 5, 2019</last_update_submitted>
  <last_update_submitted_qc>November 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diffuse large B-cell lymphoma (DLBCL)</keyword>
  <keyword>Hodgkin lymphoma</keyword>
  <keyword>metastatic breast cancer.</keyword>
  <keyword>non-small cell lung cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01660776
org study id: 2011-A01163-38
secondary id: B111181-40
secondary id: 11/32-821
nct id: NCT01660776
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Diffuse large B-cell lymphomas (DLBCLs) represent 25 to 30% of adult non-Hodgkin lymphomas in
      western countries. DLBCLs are aggressive cancer but potentially curable with multi-agent
      chemotherapy. Whereas R-CHOP regimen has led to a marked improvement in survival, this
      disease remains a biologically heterogeneous entity. New therapeutic strategies are required
      including identification of patients' subgroups with different prognostic.

      This project is based on BMS_LyTrans and Goelams 075 clinical trial. A study of whole blood
      transcriptome in 75 DLBCL patients and in 87 controls showed that PD-L1 (CD274) gene was
      overexpressed in DLBCL patients. Preliminary results demonstrated that PD-L1 is detected in
      plasma of DLBCL patients with a significantly higher concentration than in controls. This
      protein was selected as a potential biomarker because of its established role in anti-tumoral
      immunity. Interaction between PD-L1 and its receptor PD-1 is known to inhibit activation of
      immune responses by inducing T-lymphocytes anergy and/or apoptosis. Moreover, a direct
      involvement of PD-L1 in the protection of cancer cells from lysis by activated T lymphocytes
      has been demonstrated. PD-L1 expression has been described in several solid tumours,
      including ovary cancer, breast cancer, colon cancer, renal cell carcinoma, non-small cell
      lung carcinoma and in hematological malignancies such as T-NHL, MM and Hodgkin's lymphoma.
      Furthermore the expression of PD-L1 by tumour cells is associated with poor prognosis. The
      blockade of PD-L1/PD-1 axis may represent a novel therapeutic approach in aggressive cancers.
      These first results incite to identify the cells releasing soluble PD-L1 and to investigate
      its role in the anti-tumoral immunity in DLBCL patients.

      The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at
      diagnosis in comparison to others tumours known to express PD-L1 (metastatic breast cancer,
      Hodgkin's lymphoma, non-small cell lung cancer).
Secondary purposes are :

        -  To confirm the presence of plasma soluble form of PD-L1 in others malignancies

        -  To study surface expression of PD-L1 on circulating tumour cells with multiparameter fow
           cytometry and Veridex® technology in DLBCL and metastatic breast cancer patients

        -  To study surface expression of PD-L1 on circulating endothelial cells in DLBCL, Hodgkin
           lymphoma and metastatic breast cancer patients (subpart ended in late 2012)

        -  To study surface expression of PD-L1 on different types of leukocytes (monocytes, B and
           T lymphocytes)

        -  To separate circulating tumour cells expressing PD-L1 by immunomagnetic or Cell-sorting
           method

        -  To develop ELISPOT technique to study the release of soluble PD-L1 in culture
           supernatants of selected cells (subpart ended mid 2013)

        -  to evaluate the correlation between the expression of PD-L1 in the plasma and *) the
           expression of PD-L1 in the tumor, **) the expression of PD-L1 and other molecules in the
           bronchoalveolar liquid (whenever available from routine) in non-small cell lung cancer

        -  to evaluate the response to treatment according to plasma PD-L1 expression in non-small
           cell lung cancer

        -  to evaluate the susceptibility to develop a disease according to the single nucleotide
           polymorphisms of the PD-L1 gene in DLBCL and non-small cell lung cancer

        -  Constitution of the different cohorts and collection of samples Main cohort : de novo
           DLBCL at diagnosis Secondary cohorts: Hodgkin's lymphoma, metastatic breast cancer, non
           small cell lung cancer Control cohorts : healthy volunteers (blood donors), patients
           with immune thrombocytopenia (ITP)

        -  Quantification of plasma soluble PD-L1 in the different cohorts
observational model: Case-Crossover
time perspective: Prospective
measure: Description of one or several blood cell types producing soluble PD-L1 in DLBCL, metastatic breast cancer, Hodgkin's lymphoma and non-small cell lung cancer
time frame: 4 years
description: Description of one or several blood cell types producing soluble PD-L1 in DLBCL, metastatic breast cancer, Hodgkin's lymphoma and non-small cell lung cancer
measure: Analysis of PD-L1 membrane protein expression on circulating tumor cells by multiparameter flow cytometry and Veridex® in DLBCL and metastatic breast cancer, and bone marrow tumor cells by flow cytometry in DLBCL
time frame: 4 years
description: Analysis of PD-L1 membrane protein expression on circulating tumor cells by multiparameter flow cytometry and Veridex® in DLBCL and metastatic breast cancer, and bone marrow tumor cells by flow cytometry in DLBCL
measure: Analysis of PD-L1 membrane protein expression on circulating endothelial cells with the Veridex® technology in DLBCL, Hodgkin's lymphoma and metastatic breast cancer (subpart ended in late 2012)
time frame: 4 years
description: Analysis of PD-L1 membrane protein expression on circulating endothelial cells with the Veridex® technology in DLBCL, Hodgkin's lymphoma and metastatic breast cancer (subpart ended in late 2012)
measure: Analysis of PD-L1 membrane protein expression on monocytes, B and T lymphocytes in all cohorts
time frame: 4 years
description: Analysis of PD-L1 membrane protein expression on monocytes, B and T lymphocytes in all cohorts
measure: Development of an ELISPOT technique to detect soluble PD-L1 in the supernatants of sorted primary cells (subpart ended mid 2013)
time frame: 4 years
description: Development of an ELISPOT technique to detect soluble PD-L1 in the supernatants of sorted primary cells (subpart ended mid 2013)
measure: Evaluation of the techniques (by immunomagnetic or cell-sorting) used to separate circulating tumor cells expressing PD-L1
time frame: 4 years
description: Evaluation of the techniques (by immunomagnetic or cell-sorting) used to separate circulating tumor cells expressing PD-L1
measure: Correlation between the PD-L1 expression *) in the plasma, **) in the tumor and ***) in the bronchoalveolar liquid in non-small cell lung cancer
time frame: 4 years
description: Correlation between the PD-L1 expression *) in the plasma, **) in the tumor and ***) in the bronchoalveolar liquid in non-small cell lung cancer
measure: Evaluation of the response to treatment according to soluble PD-L1 expression in non-small cell lung cancer
time frame: 4 years
description: Evaluation of the response to treatment according to soluble PD-L1 expression in non-small cell lung cancer
measure: Evaluation of the susceptibility to develop a disease according to PD-L1 gene SNP in DLBCL and non-small cell lung cancer
time frame: 4 years
description: Evaluation of the susceptibility to develop a disease according to PD-L1 gene SNP in DLBCL and non-small cell lung cancer
arm group label: DLBCL (diffuse large B-cell lymphoma)
description: DLBCL (diffuse large B-cell lymphoma)
arm group label: Hodgkin's lymphoma
description: Hodgkin's lymphoma
arm group label: metastatic breast cancer
description: metastatic breast cancer or with lymph node involvement
arm group label: immune thrombocytopenia (ITP)
description: immune thrombocytopenia (ITP)
arm group label: healthy volunteers
description: healthy volunteers
arm group label: non-small cell lung cancer
description: non-small cell lung cancer
Biomedical research on total blood at diagnosis.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thierry Fest, MD
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Lymphoma, B-Cell
mesh term: Hodgkin Disease
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Breast Neoplasms