<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/NCT01692873</url>
  </required_header>
  <id_info>
    <org_study_id>PACAomics / IPC 2011-004</org_study_id>
    <nct_id>NCT01692873</nct_id>
  </id_info>
  <brief_title>Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors</brief_title>
  <acronym>PACAomics</acronym>
  <official_title>Research for Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors - PACAomics / IPC 2011-004</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Paoli-Calmettes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Paoli-Calmettes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pancreatic cancer is among the most serious human neoplasia and the most difficult to treat.&#xD;
&#xD;
      Most patients present at diagnosis a non resectable, locally advanced or metastatic disease,&#xD;
      with a median survival of 12 month.&#xD;
&#xD;
      The aim of this study is the identification of diagnosis biomarkers, predictive of the&#xD;
      therapeutic response.&#xD;
&#xD;
      This project investigate the use of molecular analyses applied to pancreatic tumor cells&#xD;
      collected by microbiopsy under ultrasound-endoscopy, and blood cells.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biomarkers</measure>
    <time_frame>within twenty four hours</time_frame>
    <description>Genomics, transcriptomics and proteomics analyses to determine presence or absence of biomarkers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histology</measure>
    <time_frame>within twenty four hours</time_frame>
    <description>To determine the histologic characteristics of the pancreatic tumor</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">274</enrollment>
  <condition>Pancreatic Tumor</condition>
  <arm_group>
    <arm_group_label>suspected pancreatic tumor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Realization of pancreatic tumor biopsy and blood samples</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>suspected pancreatic tumor</intervention_name>
    <description>Realization of pancreatic surgery to obtain tumor biopsy and blood samples to realize biomarkers analyses.</description>
    <arm_group_label>suspected pancreatic tumor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspicion of pancreatic adenocarcinoma&#xD;
&#xD;
          -  Patient &gt; 18 years old&#xD;
&#xD;
          -  Social Security affiliation&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient in emergency situation&#xD;
&#xD;
          -  Major person being the object of a legal protective measure or unable to express its&#xD;
             consent&#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>Marine GILABERT, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Paoli-Calmettes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marine GILABERT, MD</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.institutpaolicalmettes.fr/</url>
    <description>official web site of the sponsor</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>August 10, 2018</last_update_submitted>
  <last_update_submitted_qc>August 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pancreatic tumor</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/NCT01692873
org study id: PACAomics / IPC 2011-004
nct id: NCT01692873
lead sponsor: 
has dmc: No
Pancreatic cancer is among the most serious human neoplasia and the most difficult to treat.

      Most patients present at diagnosis a non resectable, locally advanced or metastatic disease,
      with a median survival of 12 month.

      The aim of this study is the identification of diagnosis biomarkers, predictive of the
      therapeutic response.

      This project investigate the use of molecular analyses applied to pancreatic tumor cells
      collected by microbiopsy under ultrasound-endoscopy, and blood cells.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Biomarkers
time frame: within twenty four hours
description: Genomics, transcriptomics and proteomics analyses to determine presence or absence of biomarkers
measure: Histology
time frame: within twenty four hours
description: To determine the histologic characteristics of the pancreatic tumor
arm group label: suspected pancreatic tumor
arm group type: Experimental
description: Realization of pancreatic tumor biopsy and blood samples
intervention type: Procedure
intervention name: suspected pancreatic tumor
description: Realization of pancreatic surgery to obtain tumor biopsy and blood samples to realize biomarkers analyses.
arm group label: suspected pancreatic tumor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marine GILABERT, MD
role: Principal Investigator
affiliation: Institut Paoli-Calmettes
facility: 
country: France
url: http://www.institutpaolicalmettes.fr/
description: official web site of the sponsor
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms