<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/NCT03037177</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0721</org_study_id>
    <nct_id>NCT03037177</nct_id>
  </id_info>
  <brief_title>Mediastinal Grey Zone Lymphoma From the LYSA</brief_title>
  <official_title>Mediastinal Grey Zone Lymphoma: Clinico-pathological Characteristics and Outcomes of 99 Patients From the LYSA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <brief_summary>
    <textblock>
      Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical&#xD;
      Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the&#xD;
      literature. Investigators report the clinical characteristics and outcomes of a large&#xD;
      retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a&#xD;
      consensus established for the diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EFS in the global population of GZL</measure>
    <time_frame>EFS: Event Free Survival from date of randomization until the date of first documented progression, up to 130 months</time_frame>
    <description>Event-free survival (EFS) was calculated from the date of diagnosis to the date of progression, a change of therapy that was not initially scheduled (radiotherapy, high-dose therapy with autologous stem cell transplantation and other unplanned treatments) or death from any cause.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">99</enrollment>
  <condition>Mediastinal Grey Zone Lymphoma</condition>
  <arm_group>
    <arm_group_label>CHL like GZL</arm_group_label>
    <description>Classical Hodgkin Lymphoma like Grey Zone Lymphoma (morphology of CHL and phenotype of PMBCL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PMBCL like GZL</arm_group_label>
    <description>Primary Mediastinal B Cell Lymphoma like Grey Zone Lymphoma(morphology of PMBCL and phenotype of CHL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Composite</arm_group_label>
    <description>with a morphology of CHL on the one side and of PMBCL on the other side of the same diagnosis biopsy</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      clinical characteristics and outcomes of a large retrospective series of 99 cases centrally&#xD;
      reviewed by a panel of hematopathologists.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We retrospectively identified cases treated in French, Belgium and Portuguese LYSA centers&#xD;
        suspected to be MGZL using local pathological records, records from LYSA centers and the&#xD;
        LYMPHOPATH network, which aims to review all newly diagnosed lymphoma cases in France (14).&#xD;
        All the FFPE blocks and immunohistochemistry (IHC) slides (obtained prior any treatment)&#xD;
        were centralized in the LYSA-Pathology (LYSA-P) department located in Henri Mondor hospital&#xD;
        in Paris to perform a central review by a panel of hematopathologists. Two hundred and four&#xD;
        cases were reviewed by the panel of LYSA hematopathologists.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cases with an intermediate morphology and phenotype between CHL and PMBCL were&#xD;
             included after central pathological review&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cases of CHL with partial CD20 expression or low expression in tumoral cells were&#xD;
             excluded and considered as CD20-positive CHL&#xD;
&#xD;
          -  Exclusion of sequential form patients (with a diagnostic biopsy of PMBCL and a relapse&#xD;
             biopsy of CHL or vise-versa) as they represent a biases for statistical analysis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre hospitalier Lyon sud</name>
      <address>
        <city>Pierre Bénite</city>
        <state>Rhône Alpes</state>
        <zip>69126</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</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/NCT03037177
org study id: 69HCL16_0721
nct id: NCT03037177
lead sponsor: 
Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical
      Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the
      literature. Investigators report the clinical characteristics and outcomes of a large
      retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a
      consensus established for the diagnosis.
observational model: Other
time perspective: Retrospective
measure: EFS in the global population of GZL
time frame: EFS: Event Free Survival from date of randomization until the date of first documented progression, up to 130 months
description: Event-free survival (EFS) was calculated from the date of diagnosis to the date of progression, a change of therapy that was not initially scheduled (radiotherapy, high-dose therapy with autologous stem cell transplantation and other unplanned treatments) or death from any cause.
arm group label: CHL like GZL
description: Classical Hodgkin Lymphoma like Grey Zone Lymphoma (morphology of CHL and phenotype of PMBCL)
arm group label: PMBCL like GZL
description: Primary Mediastinal B Cell Lymphoma like Grey Zone Lymphoma(morphology of PMBCL and phenotype of CHL)
arm group label: Composite
description: with a morphology of CHL on the one side and of PMBCL on the other side of the same diagnosis biopsy
clinical characteristics and outcomes of a large retrospective series of 99 cases centrally
      reviewed by a panel of hematopathologists.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Lymphoma