<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/NCT01715961</url>
  </required_header>
  <id_info>
    <org_study_id>CHB 11-02</org_study_id>
    <nct_id>NCT01715961</nct_id>
  </id_info>
  <brief_title>Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma</brief_title>
  <acronym>SARCOPENIE</acronym>
  <official_title>Multicentric Prospective Study to Assess the Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Henri Becquerel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Henri Becquerel</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is a multicentric prospective study to assess the clinical and prognostic&#xD;
      value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sarcopenia status is assessed by CT scan imaging on the overall survival at 18 months in&#xD;
      patients older than 70 years with diffuse large B-cell lymphoma treated by R-CHOP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression free survival</measure>
    <time_frame>at 18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>at 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of over grade 2 toxicities</measure>
    <time_frame>at the first and second courses of chemotherapy (day 21 and day 42)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>determination of both molecular subtypes GCB and ABC</measure>
    <time_frame>at 24 months</time_frame>
    <description>according DASL technology (c-DNA mediated annealing selection extension and ligation)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <condition>Grade IIIB Follicular Lymphoma</condition>
  <arm_group>
    <arm_group_label>anthropometric measurement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The muscle area assessed by CT scan imaging at a lumbar vertebral landmark (L3) at the time of diagnosis, at the end of treatment, at 12 and 18 months&#xD;
anthropometric measures (weight, height, BMI, brachial and calf circumference) and MNA (mini nutritional assessment)&#xD;
albuminemia, transthyretin, orosomucoid, CRP&#xD;
functional test to attest the muscular strength: hand grip test, unipodal test, up and go test&#xD;
hematological and non-hematological chemotherapy toxicities of cycle 1 and cycle 2&#xD;
OS and PFS at 18 and 24 months&#xD;
GCB and ABC phenotypes determined by immunohistochemistry and transcriptome analysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>anthropometric measurement</intervention_name>
    <description>To attest the muscular strength: hand grip test, balance test, up and go test</description>
    <arm_group_label>anthropometric measurement</arm_group_label>
    <other_name>Hand Grip strength test</other_name>
    <other_name>Timed get up and go test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt;= 70 years&#xD;
&#xD;
          -  DLBCL, grade IIIB follicular lymphoma or histologically proven transformed low grade&#xD;
             lymphoma&#xD;
&#xD;
          -  Whatever the IPI score and the performance status&#xD;
&#xD;
          -  Treated by Rituximab-CHOP or Rituximab-mini-CHOP&#xD;
&#xD;
          -  CT scan imaging performed one month or less before inclusion&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No initial CT scan imaging performed more than one month before inclusion&#xD;
&#xD;
          -  Positivity for HCV, HBV and HIV&#xD;
&#xD;
          -  Anthracycline contra-indication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabrice JARDIN, MD;PhD</last_name>
    <role>Study Director</role>
    <affiliation>Centre Henri Becquerel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>April 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 4, 2016</last_update_submitted>
  <last_update_submitted_qc>October 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>70 years old</keyword>
  <keyword>DLBCL</keyword>
  <keyword>Rituximab-CHOP</keyword>
  <keyword>Sarcopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Sarcopenia</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/NCT01715961
org study id: CHB 11-02
nct id: NCT01715961
lead sponsor: 
has dmc: Yes
This clinical trial is a multicentric prospective study to assess the clinical and prognostic
      value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.
Sarcopenia status is assessed by CT scan imaging on the overall survival at 18 months in
      patients older than 70 years with diffuse large B-cell lymphoma treated by R-CHOP.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: progression free survival
time frame: at 18 months
measure: progression free survival
time frame: at 24 months
measure: rate of over grade 2 toxicities
time frame: at the first and second courses of chemotherapy (day 21 and day 42)
measure: determination of both molecular subtypes GCB and ABC
time frame: at 24 months
description: according DASL technology (c-DNA mediated annealing selection extension and ligation)
arm group label: anthropometric measurement
arm group type: Other
description: The muscle area assessed by CT scan imaging at a lumbar vertebral landmark (L3) at the time of diagnosis, at the end of treatment, at 12 and 18 months
anthropometric measures (weight, height, BMI, brachial and calf circumference) and MNA (mini nutritional assessment)
albuminemia, transthyretin, orosomucoid, CRP
functional test to attest the muscular strength: hand grip test, unipodal test, up and go test
hematological and non-hematological chemotherapy toxicities of cycle 1 and cycle 2
OS and PFS at 18 and 24 months
GCB and ABC phenotypes determined by immunohistochemistry and transcriptome analysis
intervention type: Procedure
intervention name: anthropometric measurement
description: To attest the muscular strength: hand grip test, balance test, up and go test
arm group label: anthropometric measurement
other name: Hand Grip strength test
other name: Timed get up and go test
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Fabrice JARDIN, MD;PhD
role: Study Director
affiliation: Centre Henri Becquerel
facility: 
country: France
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Sarcopenia
sharing ipd: No