<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/NCT01690715</url>
  </required_header>
  <id_info>
    <org_study_id>HSL 2012/06</org_study_id>
    <nct_id>NCT01690715</nct_id>
  </id_info>
  <brief_title>Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery</brief_title>
  <acronym>HSL2012-06</acronym>
  <official_title>Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Sirio-Libanes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Sirio-Libanes</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A retrospective study based on analysis of medical records of patients with hepatocellular&#xD;
      carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with&#xD;
      diagnosis confirmed by imaging or histological specimen underwent surgical resection with&#xD;
      curative intent. The study aims to determine the prognostic value of vascular complications&#xD;
      related to cancer and to evaluate the survival rate of these patients, comparing the data&#xD;
      with those reported in the literature.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    There was recruted subject&#xD;
  </why_stopped>
  <start_date>July 2012</start_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>Prognosis (disease graduation)</measure>
    <time_frame>1 to 3 years</time_frame>
    <description>The carcinoma prognosis in the presence of vascular complications related to cancer, characterized by invasion or portal vein thrombosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival rate in years</measure>
    <time_frame>1 to 3 years</time_frame>
    <description>Determination of the survival rate within 1 to 3 years for those submitted to curative hepatectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation established between survival and degree of underlying liver dysfunction</measure>
    <time_frame>1 to 3 years</time_frame>
    <description>Investigate a possible relationship between survival and degree of underlying liver dysfunction in patients with thrombosis or portal vein invasion in patients undergoing curative hepatectomy.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Portal Vein Thrombosis</condition>
  <condition>Hepatic Portal Vein Tumor Invasion</condition>
  <arm_group>
    <arm_group_label>Hepatocellular carcinoma underwent surgery</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with hepatocellular carcinoma confirmed by imaging or histological&#xD;
        specimen underwent surgical resection with curative intent with the presence of venous&#xD;
        outflow obstruction, either by direct tumor invasion or thrombosis, on portal vein or one&#xD;
        of its main vessels.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hepatocellular carcinoma confirmed by imaging or histological specimen underwent&#xD;
             surgical resection, with or without hepatic cirrhosis association;&#xD;
&#xD;
          -  presence of venous outflow obstruction, either by direct tumor invasion or thrombosis,&#xD;
             on portal vein or one of its main vessels;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing prior systemic treatment;&#xD;
&#xD;
          -  Patients presenting incomplete data that do not allow their classification according&#xD;
             to the stratification models;&#xD;
&#xD;
          -  Patients whose information of progression or death can not be recovered;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Sírio-Libanês</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>February 19, 2018</last_update_submitted>
  <last_update_submitted_qc>February 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Sirio-Libanes</investigator_affiliation>
    <investigator_full_name>Frederico Perego Costa</investigator_full_name>
    <investigator_title>Attending physician</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>Thrombosis</keyword>
  <keyword>Portal Vein Invasion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Thrombosis</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/NCT01690715
org study id: HSL 2012/06
nct id: NCT01690715
lead sponsor: 
has dmc: Yes
A retrospective study based on analysis of medical records of patients with hepatocellular
      carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with
      diagnosis confirmed by imaging or histological specimen underwent surgical resection with
      curative intent. The study aims to determine the prognostic value of vascular complications
      related to cancer and to evaluate the survival rate of these patients, comparing the data
      with those reported in the literature.
observational model: Cohort
time perspective: Retrospective
measure: Prognosis (disease graduation)
time frame: 1 to 3 years
description: The carcinoma prognosis in the presence of vascular complications related to cancer, characterized by invasion or portal vein thrombosis.
measure: Survival rate in years
time frame: 1 to 3 years
description: Determination of the survival rate within 1 to 3 years for those submitted to curative hepatectomy.
measure: Relation established between survival and degree of underlying liver dysfunction
time frame: 1 to 3 years
description: Investigate a possible relationship between survival and degree of underlying liver dysfunction in patients with thrombosis or portal vein invasion in patients undergoing curative hepatectomy.
arm group label: Hepatocellular carcinoma underwent surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital Sirio-Libanes
investigator full name: Frederico Perego Costa
investigator title: Attending physician
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Thrombosis