<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/NCT02978898</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0564</org_study_id>
    <nct_id>NCT02978898</nct_id>
  </id_info>
  <brief_title>CD180 Overexpression in Follicular Lymphoma</brief_title>
  <official_title>CD180 Overexpression in Follicular Lymphoma Is Restricted to the Lymph Node Compartment</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>
      Background:Altered Toll-like receptor (TLR) expression levels and/or mutations in its&#xD;
      signaling pathway (such as MyD88 mutation) contribute to the pathogenesis of&#xD;
      lymphoproliferative disorders (LPD). CD180 is an orphan member of the TLR family that&#xD;
      modulates the signaling of several TLRs, but only limited studies have evaluated its&#xD;
      expression by flow cytometry (FCM) in LPD.&#xD;
&#xD;
      Methods: Using a multiparameter FCM approach, biologists have assessed CD180 mean&#xD;
      fluorescence intensity (MFI) in lymph nodes (LNs) and peripheral blood (PB) samples obtained&#xD;
      from patients with follicular lymphoma (FL; LN/PB, n=44/n=15), chronic lymphocytic leukemia&#xD;
      (CLL, n=26/n=21), mantle cell lymphoma (MCL, n=13/n=17), and marginal zone lymphoma (MZL,&#xD;
      n=16/n=12). Specimens from non-tumoral PB and LN (n=8/n=12) were used as controls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Immunophenotype Analysis by Flow Cytometry of lymph nodes samples at inclusion</measure>
    <time_frame>At inclusion, day 0.</time_frame>
    <description>Using a multiparameter FCM approach, biologists assessed the CD180 expression by our routine antigen panel in LN suspensions as well as in PB samples. Samples were analyzed on a BD FACSCanto II cytometer (BD FACS DIVA software; Becton Dickinson, San Jose, CA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immunophenotype Analysis by Flow Cytometry of peripheral blood samples at inclusion</measure>
    <time_frame>At inclusion, day 0.</time_frame>
    <description>Using a multiparameter FCM approach, biologists assessed the CD180 expression by our routine antigen panel in LN suspensions as well as in PB samples. Samples were analyzed on a BD FACSCanto II cytometer (BD FACS DIVA software; Becton Dickinson, San Jose, CA).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">184</enrollment>
  <condition>Follicular Lymphoma</condition>
  <arm_group>
    <arm_group_label>LN Lymph nodes</arm_group_label>
    <description>Samples obtained from patients with :&#xD;
LF: Follicular lymphoma MCL: Mantle cell lymphoma CLL/SLL: chronic lymphocytic leukemia/small lymphocytic leukemia MZL : splenic marginal zone Clt :control B-cells</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PB peripheral blood</arm_group_label>
    <description>Samples obtained from patients with :&#xD;
LF: Follicular lymphoma MCL: Mantle cell lymphoma CLL/SLL: chronic lymphocytic leukemia/small lymphocytic leukemia MZL : splenic marginal zone Clt :control B-cells</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Using a multiparameter FCM approach, biologists have assessed CD180 mean fluorescence&#xD;
      intensity (MFI) in lymph nodes (LNs) and peripheral blood (PB) samples obtained from patients&#xD;
      with follicular lymphoma (FL; LN/PB, n544/n515), chronic lymphocytic leukemia (CLL,&#xD;
      n526/n521), mantle cell lymphoma (MCL, n513/n517), and marginal zone lymphoma (MZL,&#xD;
      n516/n512). Specimens from non-tumoral PB and LN (n58/n512) were used as controls.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        99 LN (lymph nodes) and 65 PB (peripheral blood) samples obtained from patients diagnosed&#xD;
        with LPDs in our institution between 2012 and 2014 were evaluated for CD180 expression by&#xD;
        FCM. The diagnosis were made according to the WHO 2008 classification, including clinical&#xD;
        and morphological analysis, immunophenotyping, and conventional and molecular cytogenetics&#xD;
        (and/or fluorescent in situ hybridization). The diagnoses were follicular lymphoma (FL)&#xD;
        (LN, n=44; PB, n=15), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL)/CLL&#xD;
        (LN, n=26; PB, n=21), MCL (LN, n=13; PB,n=17), and MZL (LN, n=16; PB, n=12). All PB samples&#xD;
        presented circulating neoplastic B-cells, and in several cases, the diagnosis was made at&#xD;
        the same time in LN and PB FL, n=4; SLL/CLL, n=18; MCL, n=5. MZL, n=6.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Samples from patients with:&#xD;
&#xD;
               -  LF: Follicular lymphoma&#xD;
&#xD;
               -  MCL: Mantle cell lymphoma&#xD;
&#xD;
               -  CLL/SLL: chronic lymphocytic leukemia/small lymphocytic leukemia&#xD;
&#xD;
               -  MZL : splenic marginal zone&#xD;
&#xD;
               -  Clt :control B-cells&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient &lt;18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Mestrallet F, Sujobert P, Sarkozy C, Traverse-Glehen A, Callet-Bauchu E, Magaud JP, Salles G, Baseggio L. CD180 overexpression in follicular lymphoma is restricted to the lymph node compartment. Cytometry B Clin Cytom. 2016 Sep;90(5):433-9. doi: 10.1002/cyto.b.21331. Epub 2015 Dec 11.</citation>
    <PMID>26482097</PMID>
  </results_reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Follicular Lymphoma</keyword>
  <keyword>flow cytometry</keyword>
  <keyword>CD180</keyword>
  <keyword>Toll-like receptor</keyword>
  <keyword>lymphoproliferative disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Follicular</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/NCT02978898
org study id: 69HCL16_0564
nct id: NCT02978898
lead sponsor: 
Background:Altered Toll-like receptor (TLR) expression levels and/or mutations in its
      signaling pathway (such as MyD88 mutation) contribute to the pathogenesis of
      lymphoproliferative disorders (LPD). CD180 is an orphan member of the TLR family that
      modulates the signaling of several TLRs, but only limited studies have evaluated its
      expression by flow cytometry (FCM) in LPD.

      Methods: Using a multiparameter FCM approach, biologists have assessed CD180 mean
      fluorescence intensity (MFI) in lymph nodes (LNs) and peripheral blood (PB) samples obtained
      from patients with follicular lymphoma (FL; LN/PB, n=44/n=15), chronic lymphocytic leukemia
      (CLL, n=26/n=21), mantle cell lymphoma (MCL, n=13/n=17), and marginal zone lymphoma (MZL,
      n=16/n=12). Specimens from non-tumoral PB and LN (n=8/n=12) were used as controls.
observational model: Cohort
time perspective: Retrospective
measure: Immunophenotype Analysis by Flow Cytometry of lymph nodes samples at inclusion
time frame: At inclusion, day 0.
description: Using a multiparameter FCM approach, biologists assessed the CD180 expression by our routine antigen panel in LN suspensions as well as in PB samples. Samples were analyzed on a BD FACSCanto II cytometer (BD FACS DIVA software; Becton Dickinson, San Jose, CA).
measure: Immunophenotype Analysis by Flow Cytometry of peripheral blood samples at inclusion
time frame: At inclusion, day 0.
description: Using a multiparameter FCM approach, biologists assessed the CD180 expression by our routine antigen panel in LN suspensions as well as in PB samples. Samples were analyzed on a BD FACSCanto II cytometer (BD FACS DIVA software; Becton Dickinson, San Jose, CA).
arm group label: LN Lymph nodes
description: Samples obtained from patients with :
LF: Follicular lymphoma MCL: Mantle cell lymphoma CLL/SLL: chronic lymphocytic leukemia/small lymphocytic leukemia MZL : splenic marginal zone Clt :control B-cells
arm group label: PB peripheral blood
description: Samples obtained from patients with :
LF: Follicular lymphoma MCL: Mantle cell lymphoma CLL/SLL: chronic lymphocytic leukemia/small lymphocytic leukemia MZL : splenic marginal zone Clt :control B-cells
Using a multiparameter FCM approach, biologists have assessed CD180 mean fluorescence
      intensity (MFI) in lymph nodes (LNs) and peripheral blood (PB) samples obtained from patients
      with follicular lymphoma (FL; LN/PB, n544/n515), chronic lymphocytic leukemia (CLL,
      n526/n521), mantle cell lymphoma (MCL, n513/n517), and marginal zone lymphoma (MZL,
      n516/n512). Specimens from non-tumoral PB and LN (n58/n512) were used as controls.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
citation: Mestrallet F, Sujobert P, Sarkozy C, Traverse-Glehen A, Callet-Bauchu E, Magaud JP, Salles G, Baseggio L. CD180 overexpression in follicular lymphoma is restricted to the lymph node compartment. Cytometry B Clin Cytom. 2016 Sep;90(5):433-9. doi: 10.1002/cyto.b.21331. Epub 2015 Dec 11.
PMID: 26482097
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular