<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/NCT04436679</url>
  </required_header>
  <id_info>
    <org_study_id>2019_29</org_study_id>
    <secondary_id>2019-A02001-56</secondary_id>
    <nct_id>NCT04436679</nct_id>
  </id_info>
  <brief_title>INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors</brief_title>
  <acronym>CaPaLong</acronym>
  <official_title>INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      The study is particularly innovative as it will accurately analyze the microscopic&#xD;
      characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the&#xD;
      pancreas, using a comparative approach of long-survivor/short-survival patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 2, 2021</start_date>
  <completion_date type="Anticipated">February 2025</completion_date>
  <primary_completion_date type="Anticipated">February 2025</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>Relationship between known prognostic histological markers of pancreatic adenocarcinoma and patient survival.</measure>
    <time_frame>at 2 years</time_frame>
    <description>Tissue analysis will be performed by conventional microscopy and will evaluate histological markers known in the literature to have a prognostic impact.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship between newly described histological markers for pancreatic adenocarcinoma and patient survival.</measure>
    <time_frame>at 2 years</time_frame>
    <description>Immunohistochemistry tissue analysis. It will allow the evaluation of newly described histological markers for pancreatic adenocarcinoma, which could have a prognostic impact such as the immunophenotype of the inflammatory infiltrate, the expression of the mucins MUC1, MUC5AC, MUC4, MUC16, mesothelin, p53, Ki67 (MIB1) and markers of aggressive subtypes identified by transcriptome studies, in particular the basal-like molecular subtype.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Pancreas Cancer</condition>
  <condition>Pancreatic Adenocarcinoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      tissues paraffin lumbered paraffin blocks of tissue-microarrays&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pancreatic adenocarcinoma patients operated on between 2001 and 2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years of age at diagnosis&#xD;
&#xD;
          -  Primary pancreatic cancer patients operated on in one of the 4 centres between 2001&#xD;
             and 2016&#xD;
&#xD;
          -  Histopathological diagnosis of excreto-pancreatic adenocarcinoma of the pancreas,&#xD;
             ductal adenocarcinoma or classical adenocarcinoma&#xD;
&#xD;
          -  Tissue blocks (FFPE) available (tumour/healthy tissue)&#xD;
&#xD;
          -  Affiliated to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of Primary Cancer Tissue Blocks (PCTBs)&#xD;
&#xD;
          -  Paraffin block fixed in Bouin or AFA&#xD;
&#xD;
          -  Patient Refusal&#xD;
&#xD;
          -  Pancreatic cancer not corresponding to a conventional excretopancreatic adenocarcinoma&#xD;
             such as: carcinoma on intraductal papillary mucinous neoplasm, endocrine&#xD;
             tumor/carcinoma, acinar cell carcinoma, ...).&#xD;
&#xD;
          -  Patient died due to post-surgical complications (death within 30 days post-surgery).&#xD;
&#xD;
          -  Surgical resection of macroscopic R2 type.&#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>Emmanuelle Leteurtre, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Emmanuelle Leteurtre, MD,PhD</last_name>
    <phone>0320445556</phone>
    <phone_ext>+33</phone_ext>
    <email>emmanuelle.leteurtre@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hop Claude Huriez Chu Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>0320445962</phone>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>survival</keyword>
  <keyword>prognosis</keyword>
  <keyword>tissue</keyword>
  <keyword>pancreas cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</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/NCT04436679
org study id: 2019_29
secondary id: 2019-A02001-56
nct id: NCT04436679
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is particularly innovative as it will accurately analyze the microscopic
      characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the
      pancreas, using a comparative approach of long-survivor/short-survival patients.
observational model: Cohort
time perspective: Retrospective
measure: Relationship between known prognostic histological markers of pancreatic adenocarcinoma and patient survival.
time frame: at 2 years
description: Tissue analysis will be performed by conventional microscopy and will evaluate histological markers known in the literature to have a prognostic impact.
measure: Relationship between newly described histological markers for pancreatic adenocarcinoma and patient survival.
time frame: at 2 years
description: Immunohistochemistry tissue analysis. It will allow the evaluation of newly described histological markers for pancreatic adenocarcinoma, which could have a prognostic impact such as the immunophenotype of the inflammatory infiltrate, the expression of the mucins MUC1, MUC5AC, MUC4, MUC16, mesothelin, p53, Ki67 (MIB1) and markers of aggressive subtypes identified by transcriptome studies, in particular the basal-like molecular subtype.
tissues paraffin lumbered paraffin blocks of tissue-microarrays
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emmanuelle Leteurtre, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Emmanuelle Leteurtre, MD,PhD
phone: 0320445556
phone ext: +33
email: emmanuelle.leteurtre@chru-lille.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms