<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/NCT02238821</url>
  </required_header>
  <id_info>
    <org_study_id>MET/colon 06</org_study_id>
    <nct_id>NCT02238821</nct_id>
  </id_info>
  <brief_title>Role of the MET Oncogene in Human Colorectal Cancer - A Translational Study</brief_title>
  <acronym>COMET</acronym>
  <official_title>Role of the MET Oncogene in Human Colorectal Cancer. Possible Implications in the Activation of an Acquired Pro-thrombotic Condition - A Translational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione del Piemonte per l'Oncologia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione del Piemonte per l'Oncologia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MET oncogene is known to sustain the Trousseau's syndrome in murine experimental models,&#xD;
      featuring association of carcinogenesis with a blood procoagulant disorder. MET is frequently&#xD;
      overexpressed in colorectal cancer, a tumor where venous thromboembolism (VTE) may occur in&#xD;
      association with poor prognosis, but the biological and genetic factors that cause VTE are&#xD;
      still obscure.&#xD;
&#xD;
      The Investigators propose to study whether in patients harboring a surgically resectable&#xD;
      colorectal cancer the MET oncogene is expressed and may be associated with a blood&#xD;
      thrombophilic condition that favors the onset of VTE.&#xD;
&#xD;
      These data would have two main implications: (i) for the first time, a direct genetic link&#xD;
      between the MET oncogene and a procoagulant disorder would be demonstrated in humans; (ii)&#xD;
      the procoagulant alterations would have diagnostic/prognostic significance for the&#xD;
      identification of patients at risk for poor outcome, and implementation of appropriate&#xD;
      therapeutic protocols.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2007</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Scoring MET expression in colorectal tissue sections by immunohistochemical analysis</measure>
    <time_frame>After surgical resection of the tumor, approximately 3-5 days after enrollement</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Scoring the expression of Plasminogen Activator Inhibitor -1 in colorectal cancer tissue sections by Immunohistochemical analysis</measure>
    <time_frame>After surgical resection of the tumor, approximately 3-5 days after enrollement</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Scoring the expression of COX-2 in colorectal cancer tissue sections by Immunohistochemical analysis</measure>
    <time_frame>After surgical resection of the tumor, approximately 3-5 days after enrollement</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>resectable colorectal cancer</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with resectable colorectal tumor with survival prognosis&gt;6 month&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; or = 18;&#xD;
&#xD;
          -  age &lt; or = 80;&#xD;
&#xD;
          -  Clinical diagnosis of colorectal tumor by CT, MRI or endoscopy;&#xD;
&#xD;
          -  surgically resectable tumor;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inclusion in other clinical protocols requiring administration of anticoagulant drugs;&#xD;
&#xD;
          -  Life expectancy &lt; 6 month;&#xD;
&#xD;
          -  Clinical diagnosis of thrombophilic condition by laboratory analysis;&#xD;
&#xD;
          -  Previously implanted Central Venous Catheter;&#xD;
&#xD;
          -  Previous or concomitant second neoplasia;&#xD;
&#xD;
          -  Clinical diagnosis of kidney, liver or heart failure;&#xD;
&#xD;
          -  Inflammatory markers alteration associated with disease unrelated to neoplasia&#xD;
             (infection, connective tissue disease etc);&#xD;
&#xD;
          -  Severe hemostasis disorder;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paolo M Comoglio, MD</last_name>
    <role>Study Director</role>
    <affiliation>Fondazione del Piemonte per l'Oncologia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione del Piemonte per l'Oncologia</name>
      <address>
        <city>Candiolo</city>
        <state>TO</state>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>March 2, 2017</last_update_submitted>
  <last_update_submitted_qc>March 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>resectable colorectal cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02238821
org study id: MET/colon 06
nct id: NCT02238821
lead sponsor: 
has dmc: No
The MET oncogene is known to sustain the Trousseau's syndrome in murine experimental models,
      featuring association of carcinogenesis with a blood procoagulant disorder. MET is frequently
      overexpressed in colorectal cancer, a tumor where venous thromboembolism (VTE) may occur in
      association with poor prognosis, but the biological and genetic factors that cause VTE are
      still obscure.

      The Investigators propose to study whether in patients harboring a surgically resectable
      colorectal cancer the MET oncogene is expressed and may be associated with a blood
      thrombophilic condition that favors the onset of VTE.

      These data would have two main implications: (i) for the first time, a direct genetic link
      between the MET oncogene and a procoagulant disorder would be demonstrated in humans; (ii)
      the procoagulant alterations would have diagnostic/prognostic significance for the
      identification of patients at risk for poor outcome, and implementation of appropriate
      therapeutic protocols.
observational model: Other
time perspective: Prospective
measure: Scoring MET expression in colorectal tissue sections by immunohistochemical analysis
time frame: After surgical resection of the tumor, approximately 3-5 days after enrollement
measure: Scoring the expression of Plasminogen Activator Inhibitor -1 in colorectal cancer tissue sections by Immunohistochemical analysis
time frame: After surgical resection of the tumor, approximately 3-5 days after enrollement
measure: Scoring the expression of COX-2 in colorectal cancer tissue sections by Immunohistochemical analysis
time frame: After surgical resection of the tumor, approximately 3-5 days after enrollement
arm group label: resectable colorectal cancer
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Paolo M Comoglio, MD
role: Study Director
affiliation: Fondazione del Piemonte per l'Oncologia
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Colorectal Neoplasms