<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/NCT03791346</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0492</org_study_id>
    <nct_id>NCT03791346</nct_id>
  </id_info>
  <brief_title>Pancreatectomy for NET: External Evaluation of WHO 2017 Grading System</brief_title>
  <acronym>PanTEN</acronym>
  <official_title>Outcome After Pancreatectomy for Neuroendocrine Tumor and Evaluation of the WHO 2017 Grading System: a Retrospective Multicentric Analysis of 138 Consecutive Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of digestive surgery, Carémeau Hospital, 30900, Nîmes, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of oncology, Carémeau Hospital, 30900, Nîmes, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oncology - Institut du Cancer de Montpellier (ICM), Montpellier, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Digestive &amp; Oncologic Surgery - Institut du Cancer de Montpellier (ICM), Montpellier, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: The aim of this study was to investigate the clinicopathological factors and to evaluate&#xD;
      the prognostic accuracy of the new World Health Organization (WHO) 2017 grading system in&#xD;
      pancreatic neuroendocrine tumor (PanNET) patients.&#xD;
&#xD;
      Methods: Data collected between 1997 and December 2017 were analyzed. Histological grading&#xD;
      and staging was based on the WHO 2017 grading system. Outcome after surgery and predictors of&#xD;
      overall survival (OS) and disease free survival (DFS) were evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 1997</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</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>Disease-free survival at 5 years</measure>
    <time_frame>5 years</time_frame>
    <description>Disease-free survival (percentage of patients without recurrence) at 5 years. Disease-free survival (DFS) (time from diagnosis to time of first radiological evidence of local, regional, or distant relapse, or death due to any cause)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival at 5 years</measure>
    <time_frame>5 years</time_frame>
    <description>Overall survival (OS) (time from diagnosis until death, regardless of cause)</description>
  </secondary_outcome>
  <enrollment type="Actual">138</enrollment>
  <condition>Pancreatic Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective review of collected data including all consecutive patients requiring a&#xD;
        pancreatic resection for PanNET at 3 tertiary referral centers for pancreatic surgery in&#xD;
        France, between December 1997 and December 2017. The 3 centers were Digestive Surgery Units&#xD;
        of Montpellier, Nimes and Institute of Cancer at the University of Montpellier-Nimes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - patients with histologically proven neuroendocrine tumor located in pancreas who&#xD;
        underwent pancreatic resection (by open, laparoscopic or robotic approach) even in case of&#xD;
        distant metastasis at time of surgery, with no previous or concurrent malignancy.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Patients with tumors diagnosed as adenocarcinoma with scattered neuroendocrine cells or&#xD;
        with focal neuroendocrine component were excluded of this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>REGIS SOUCHE</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neuroendocrine tumor</keyword>
  <keyword>Survival</keyword>
  <keyword>WHO 2017 grading system</keyword>
  <keyword>pancreatectomy</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>Postoperative outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroendocrine Tumors</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/NCT03791346
org study id: RECHMPL18_0492
nct id: NCT03791346
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim: The aim of this study was to investigate the clinicopathological factors and to evaluate
      the prognostic accuracy of the new World Health Organization (WHO) 2017 grading system in
      pancreatic neuroendocrine tumor (PanNET) patients.

      Methods: Data collected between 1997 and December 2017 were analyzed. Histological grading
      and staging was based on the WHO 2017 grading system. Outcome after surgery and predictors of
      overall survival (OS) and disease free survival (DFS) were evaluated.
observational model: Cohort
time perspective: Retrospective
measure: Disease-free survival at 5 years
time frame: 5 years
description: Disease-free survival (percentage of patients without recurrence) at 5 years. Disease-free survival (DFS) (time from diagnosis to time of first radiological evidence of local, regional, or distant relapse, or death due to any cause)
measure: Overall survival at 5 years
time frame: 5 years
description: Overall survival (OS) (time from diagnosis until death, regardless of cause)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: REGIS SOUCHE
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Neuroendocrine Tumors