<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/NCT03266757</url>
  </required_header>
  <id_info>
    <org_study_id>N/A-NI-PANC-HeSMO-005490</org_study_id>
    <nct_id>NCT03266757</nct_id>
  </id_info>
  <brief_title>Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma</brief_title>
  <official_title>Observational Study of the Clinical Practice in Patients With Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma in Greece</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hellenic Society of Medical Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hellenic Society of Medical Oncology</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational study of the Clinical Practice in patients with Borderline resectable or&#xD;
      resectable or advanced pancreatic adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2016</start_date>
  <completion_date type="Actual">February 11, 2018</completion_date>
  <primary_completion_date type="Actual">February 11, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>clinical practice-treatments</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression Free Survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Pancreatic Adenocarcinoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Public and Private Hospital Institutions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients Age 18 or older with histologically confirmed ductal pancreatic&#xD;
             adenocarcinoma as a primary tumor&#xD;
&#xD;
          -  Patients with ductal pancreatic adenocarcinoma (Borderline resectable or resectable or&#xD;
             advanced)&#xD;
&#xD;
          -  Patients that are alive and under treatment or follow up&#xD;
&#xD;
          -  Signed informed consent (ICF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of other primary tumors&#xD;
&#xD;
          -  Pancreatic adenocarcinoma due to metastasis from other primary tumor(s)&#xD;
&#xD;
          -  Neuroendocrine or other pancreatic carcinoma other than ductal adenocarcinoma&#xD;
&#xD;
          -  Patients who refuse to provide informed 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>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>April 4, 2019</last_update_submitted>
  <last_update_submitted_qc>April 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</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>
  </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/NCT03266757
org study id: N/A-NI-PANC-HeSMO-005490
nct id: NCT03266757
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Observational study of the Clinical Practice in patients with Borderline resectable or
      resectable or advanced pancreatic adenocarcinoma.
observational model: Cohort
time perspective: Prospective
measure: clinical practice-treatments
time frame: 2 years
measure: progression Free Survival
time frame: 2 years
measure: Overall Survival
time frame: 2 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Adenocarcinoma