<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/NCT02977702</url>
  </required_header>
  <id_info>
    <org_study_id>ICL_2015_0003</org_study_id>
    <nct_id>NCT02977702</nct_id>
  </id_info>
  <brief_title>Sarcopenia is an Independent Prognostic Factor for Overall Survival in Patients With Pancreatic Adenocarcinoma</brief_title>
  <official_title>Sarcopenia is an Independent Prognostic Factor for Overall Survival in Patients With Pancreatic Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Cancérologie de Lorraine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Cancérologie de Lorraine</source>
  <brief_summary>
    <textblock>
      The primary objective of this study was to validate Total Psoas Area (TPA) measurement as an&#xD;
      independent prognostic factor of overall survival in patients with pancreatic adenocarcinoma.&#xD;
      Secondary objective was to describe the evolution of the TPA during the follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">114</enrollment>
  <condition>Pancreatic Neoplasms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients records would be extracted from the electronic health record system of Institut de&#xD;
        Cancérologie de Lorraine&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients consecutive enrolled from January 2009 to December 2015 who underwent at&#xD;
             least one chemotherapy for pancreatic adenocarcinoma, whatever the stage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A patient record captured outside the time frame from January 2009 to December 2015&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 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>Adenocarcinoma</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Sarcopenia</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/NCT02977702
org study id: ICL_2015_0003
nct id: NCT02977702
lead sponsor: 
The primary objective of this study was to validate Total Psoas Area (TPA) measurement as an
      independent prognostic factor of overall survival in patients with pancreatic adenocarcinoma.
      Secondary objective was to describe the evolution of the TPA during the follow-up.
observational model: Case-Only
time perspective: Retrospective
measure: overall survival
time frame: 24 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Pancreatic Neoplasms
mesh term: Sarcopenia