<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/NCT04415190</url>
  </required_header>
  <id_info>
    <org_study_id>2019PI274</org_study_id>
    <nct_id>NCT04415190</nct_id>
  </id_info>
  <brief_title>the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients</brief_title>
  <official_title>Multicenter Retrospective Study Evaluating the Impact of Early Palliative Care on the Survival of Patients With Locally Advanced and / or Metastatic Cholangiocarcinoma (CCK)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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 prognosis for cholangiocarcinoma is bad. Potentially, early management by a palliative&#xD;
      care team could increase overall survival. We will also assess whether early management by a&#xD;
      palliative care team could impact progression-free survival, the place of death and the date&#xD;
      of the last chemotherapy, in particular to avoid unnecessary chemotherapy cures in an&#xD;
      imminent end of life&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2020</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>Global survival</measure>
    <time_frame>baseline</time_frame>
    <description>Global survival from the diagnosis (to the death or because of lost to follow up)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>cholangiocarcinoma with early palliative care</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>cholangiocarcinoma without early palliative care</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>early palliative care</intervention_name>
    <description>early palliative care</description>
    <arm_group_label>cholangiocarcinoma with early palliative care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cholangiocarcinoma metastatic or locally advanced&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 18 years old&#xD;
&#xD;
          -  intra- or extra-hepatic CCK or histologically proven vesicular adenocarcinoma&#xD;
&#xD;
          -  Locally advanced and / or metastatic disease from the start or recurrent&#xD;
&#xD;
          -  Initial diagnosis or recurrence between 1/01/2013 and 31/12/2019&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years old&#xD;
&#xD;
          -  death less than one week after the diagnostic&#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>Anthony Lopez</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU Nancy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anthony Lopez</last_name>
    <phone>0383858585</phone>
    <email>a.lopez@chru-nancy.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lopez</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Anthony Lopez</last_name>
      <phone>0383858585</phone>
      <email>a.lopez@chru-nancy.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
    <investigator_full_name>Anthony LOPEZ</investigator_full_name>
    <investigator_title>Dr Lopez, MCU</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04415190
org study id: 2019PI274
nct id: NCT04415190
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prognosis for cholangiocarcinoma is bad. Potentially, early management by a palliative
      care team could increase overall survival. We will also assess whether early management by a
      palliative care team could impact progression-free survival, the place of death and the date
      of the last chemotherapy, in particular to avoid unnecessary chemotherapy cures in an
      imminent end of life
observational model: Cohort
time perspective: Retrospective
measure: Global survival
time frame: baseline
description: Global survival from the diagnosis (to the death or because of lost to follow up)
arm group label: cholangiocarcinoma with early palliative care
arm group label: cholangiocarcinoma without early palliative care
intervention type: Other
intervention name: early palliative care
description: early palliative care
arm group label: cholangiocarcinoma with early palliative care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anthony Lopez
role: Principal Investigator
affiliation: CHRU Nancy
last name: Anthony Lopez
phone: 0383858585
email: a.lopez@chru-nancy.fr
facility: 
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Central Hospital, Nancy, France
investigator full name: Anthony LOPEZ
investigator title: Dr Lopez, MCU
mesh term: Cholangiocarcinoma
sharing ipd: Undecided