<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/NCT02984215</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0720</org_study_id>
    <nct_id>NCT02984215</nct_id>
  </id_info>
  <brief_title>aCGH Impacts Survival in Plasma Cell PTLD</brief_title>
  <official_title>Array-CGH in Plasma Cell Post-transplantation Lymphoproliferative Disorders</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>
      Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic&#xD;
      PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD. To date,&#xD;
      there is no exhaustive published cytogenetic data on PC-PTLD. The investigators report&#xD;
      array-based comparative genomic hybridization (aCGH) of 10 cases of PCM and PLL-PTLD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 1990</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">January 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Genome wide array-based comparative genomic hybridization (aCGH)</measure>
    <time_frame>At diagnosis of PTLD, Day 0.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival according to aCGH complexity</measure>
    <time_frame>Overall survival (OS) was calculated from date of diagnosis to date of death from any cause, up to 130 months.</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Post-transplantation Lymphoproliferative Disorders</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      the investigators report array-based comparative genomic hybridization (aCGH) of 10 cases of&#xD;
      PCM and PLL-PTLD. aCGH performed on 10 plasma cell PTLD.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We conducted a retrospective analysis between 1990 and 2012 of all consecutive cases of PCM&#xD;
        and PLL-PTLD collected in the Centre Hospitalier Lyon Sud (CHLS, 6 cases) and in Necker -&#xD;
        Enfants Malades Hospital in Paris (4 cases). There were 4 females and 6 males. Among the 8&#xD;
        adults, 6 had received a kidney transplant, 1 a heart transplant and one a lung transplant.&#xD;
        Among the 2 children, one had received a heart transplant and one an allogeneic stem cell&#xD;
        transplantation with a matched unrelated donor. Immunosuppressive regimens were&#xD;
        heterogeneous.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  WHO classification 2008 as monomorphic PCM (plasma cell myeloma) or PLL (plasmacytoma&#xD;
             like lesion) / PTLD (post transplantation lymphoproliferative disorders).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other than PCM or PLL PTLD at diagnosis&#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>October 31, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</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>Lymphoproliferative Disorders</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/NCT02984215
org study id: 69HCL16_0720
nct id: NCT02984215
lead sponsor: 
Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic
      PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD. To date,
      there is no exhaustive published cytogenetic data on PC-PTLD. The investigators report
      array-based comparative genomic hybridization (aCGH) of 10 cases of PCM and PLL-PTLD.
time perspective: Retrospective
measure: Genome wide array-based comparative genomic hybridization (aCGH)
time frame: At diagnosis of PTLD, Day 0.
measure: Overall survival according to aCGH complexity
time frame: Overall survival (OS) was calculated from date of diagnosis to date of death from any cause, up to 130 months.
the investigators report array-based comparative genomic hybridization (aCGH) of 10 cases of
      PCM and PLL-PTLD. aCGH performed on 10 plasma cell PTLD.
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: Lymphoproliferative Disorders