<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/NCT02218801</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC-1409-GITCG</org_study_id>
    <nct_id>NCT02218801</nct_id>
  </id_info>
  <brief_title>A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program</brief_title>
  <acronym>CLIMB</acronym>
  <official_title>A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Society of Surgical Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective database has two main objectives;&#xD;
&#xD;
        -  to evaluate the complication rates, 30-day and 90-day mortality from different surgical&#xD;
           strategies for unresectable, borderline resectable or initially unresectable liver&#xD;
           metastasis from colorectal cancer.&#xD;
&#xD;
        -  to establish baseline quality parameters for different surgical strategies for&#xD;
           unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM)&#xD;
           patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">February 2021</completion_date>
  <primary_completion_date type="Actual">January 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Number of post-operative complications</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival after 2 years of follow-up</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival at 2 years</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of post-operative complications in the first 50 patients compared to the second 50 patients</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">219</enrollment>
  <condition>Liver Metastasis</condition>
  <condition>Colorectal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Colorectal adenocarcinoma liver metastasis</arm_group_label>
    <description>Unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of treatment for liver metastasis</intervention_name>
    <arm_group_label>Colorectal adenocarcinoma liver metastasis</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood, plasma, serum and left-over tissue samples from either primary tumor or liver&#xD;
      metastasis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with liver metastasis of colorectal adenocarcinoma (unresectable, borderline&#xD;
        resectable or initially unresectable)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With histologically proven colorectal adenocarcinoma with liver metastasis.&#xD;
&#xD;
          -  With unresectable, borderline or initially unresectable liver metastasis from a&#xD;
             colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board&#xD;
             (MDT).&#xD;
&#xD;
               -  Unresectable is defined as no possibility of completely resecting all tumor due&#xD;
                  to size, location or number of deposits.&#xD;
&#xD;
               -  Borderline is defined as potentially operable but technically or biologically&#xD;
                  more challenging to resect as evaluated by the MDT.&#xD;
&#xD;
               -  Initially unresectable is defined as metastasis that have been down-sized after&#xD;
                  conversion chemotherapy and evaluated by the MDT to be resectable&#xD;
&#xD;
          -  discussed by a multidisciplinary team before surgery.&#xD;
&#xD;
          -  Participants of the MDT must include at least one liver surgeon, one radiologist and&#xD;
             one oncologist. They will determine the resectability of the CRLM according to local&#xD;
             practice.&#xD;
&#xD;
          -  With a possibility of a surgical procedure (resection with or without portal vein&#xD;
             embolization, intraoperative local ablative technique or a combined approach) assessed&#xD;
             during the MDT.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Before patient registration, written informed consent must be given according to&#xD;
             ICH/GCP, and national/local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any psychological, familial, or sociological condition potentially hampering&#xD;
             understanding of the research project.&#xD;
&#xD;
          -  Any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin&#xD;
             cancer (unless there has been a disease-free interval of at least 5 years)&#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>Serge Evrard, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Institut Bergonié</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Graeme Poston, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Aintree University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Innsbruck Universitaetsklinik</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung</name>
      <address>
        <city>Vienna</city>
        <zip>1030</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hosptial Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Der J.W. Goethe Universitaet</name>
      <address>
        <city>Frankfurt Am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Centre</name>
      <address>
        <city>Leiden</city>
        <zip>2300</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Institute of Vojvodina</name>
      <address>
        <city>Sremska Kamenica</city>
        <zip>21204</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital De Fuenlabrada</name>
      <address>
        <city>Fuenlabrada</city>
        <zip>28942</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux universitaires de Genève - HUG</name>
      <address>
        <city>Geneve</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aintree University Hospital NHS Trust</name>
      <address>
        <city>Liverpool</city>
        <zip>GB L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>May 27, 2022</last_update_submitted>
  <last_update_submitted_qc>May 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Liver metastasis</keyword>
  <keyword>Colorectal carcinoma</keyword>
  <keyword>Unresectable</keyword>
  <keyword>Borderline resectable</keyword>
  <keyword>Initially unresectable</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
    <mesh_term>Colorectal 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/NCT02218801
org study id: EORTC-1409-GITCG
nct id: NCT02218801
lead sponsor: 
collaborator: 
has dmc: Yes
This prospective database has two main objectives;

        -  to evaluate the complication rates, 30-day and 90-day mortality from different surgical
           strategies for unresectable, borderline resectable or initially unresectable liver
           metastasis from colorectal cancer.

        -  to establish baseline quality parameters for different surgical strategies for
           unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM)
           patients.
observational model: Cohort
time perspective: Prospective
measure: Number of post-operative complications
time frame: 1 year
measure: Overall survival after 2 years of follow-up
time frame: 3 years
measure: Progression free survival at 2 years
time frame: 3 years
measure: Number of post-operative complications in the first 50 patients compared to the second 50 patients
time frame: 1 year
arm group label: Colorectal adenocarcinoma liver metastasis
description: Unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer
intervention type: Other
intervention name: Evaluation of treatment for liver metastasis
arm group label: Colorectal adenocarcinoma liver metastasis
whole blood, plasma, serum and left-over tissue samples from either primary tumor or liver
      metastasis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Serge Evrard, Prof.
role: Study Chair
affiliation: Institut Bergonié
last name: Graeme Poston, Prof.
role: Study Chair
affiliation: Aintree University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Austria
country: Belgium
country: Denmark
country: France
country: Germany
country: Italy
country: Netherlands
country: Serbia
country: Spain
country: Sweden
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Liver Neoplasms
mesh term: Colorectal Neoplasms