<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/NCT03025438</url>
  </required_header>
  <id_info>
    <org_study_id>201603013RINA</org_study_id>
    <nct_id>NCT03025438</nct_id>
  </id_info>
  <brief_title>Cytological Diagnosis of Hepatic Angiosarcoma and Its Histopathologic Correlation</brief_title>
  <official_title>Cytological Diagnosis of Hepatic Angiosarcoma and Its Histopathologic Correlation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cytological diagnosis of hepatic angiosarcoma by fine-needle aspiration (FNA) or imprint&#xD;
      cytology is difficult due not only to its various cytomorphologic features but also clinical&#xD;
      rarity. Vasoformative features, such as pseudo-acini, branching pseudo-capillary structure,&#xD;
      and intracytoplasmic lumina, are clues to achieve the diagnosis. But these features are not&#xD;
      always present. In order to find clues for cytological diagnosis of angiosarcoma, we&#xD;
      collected cases of hepatic angiosarcoma to study their cytological features. And then&#xD;
      compared these features with those in their histopathological biopsy or resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatic angiosarcoma is a rare hepatic malignant tumor. Although diagnosis of hepatic&#xD;
      angiosarcoma by FNA cytology has been reported since 1982, followed by several studies, its&#xD;
      cytomorphologic features were still not well recognized by cytopathologists because of its&#xD;
      clinical rarity and various morphologic features.&#xD;
&#xD;
      We reviewed literatures about cytomorphology of hepatic angiosarcoma by FNA. There are only&#xD;
      11 cases retrieved in 10 articles searched from Medline. The sex M/F ratio was 6/4 (one&#xD;
      unknown); age range was 56 to 79 years old. In initial cytological evaluation, four cases got&#xD;
      angiosarcoma or consistent/suspicious angiosarcoma diagnosis. Positive for malignancy,&#xD;
      sarcoma, and poorly differentiated spindle cell lesion were in one case respectively. One was&#xD;
      diagnosed as atypical cells. Remaining three were unavailable by their reports.&#xD;
&#xD;
      In cytological morphologic features, all but one met least 2 of 3 cytological cellular&#xD;
      criteria of angiosarcoma cells: spindle cells, epithelioid cells, and pleomorphic cells. In&#xD;
      cytological architectural features, 7 of 11 cases showed vasoformative structures; 5 of 11&#xD;
      cases showed intracytoplasmic lumen or erythrophagocytosis. Ten of 11 cases had&#xD;
      histologic/pathologic confirmation as angiosarcoma. One case reported interrelation of tumor&#xD;
      structures and their own accompanied liver tissue in cell blocks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">April 3, 2017</completion_date>
  <primary_completion_date type="Actual">February 4, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>all cause mortality</measure>
    <time_frame>about 10 years from the date of diagnosis to the last follow-up date by medical record</time_frame>
  </primary_outcome>
  <enrollment type="Actual">13</enrollment>
  <condition>Hepatic Angiosarcoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients of a medical center in Taiwan; National Taiwan University Hospital (NTUH)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Consecutive patients of hepatic angiosarcoma performed FNA and/or imprint cytological&#xD;
        examinations in our hospital.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patients without pathological confirmation.&#xD;
&#xD;
          2. Patients who are not angiosarcoma by pathological reviews.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wern-Cherng Cheng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital, Department of laboratory medicine</name>
      <address>
        <city>Taipei</city>
        <zip>10008</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>December 15, 2017</last_update_submitted>
  <last_update_submitted_qc>December 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>angiosarcoma</keyword>
  <keyword>Cytology</keyword>
  <keyword>liver</keyword>
  <keyword>cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemangiosarcoma</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/NCT03025438
org study id: 201603013RINA
nct id: NCT03025438
lead sponsor: 
has dmc: No
Cytological diagnosis of hepatic angiosarcoma by fine-needle aspiration (FNA) or imprint
      cytology is difficult due not only to its various cytomorphologic features but also clinical
      rarity. Vasoformative features, such as pseudo-acini, branching pseudo-capillary structure,
      and intracytoplasmic lumina, are clues to achieve the diagnosis. But these features are not
      always present. In order to find clues for cytological diagnosis of angiosarcoma, we
      collected cases of hepatic angiosarcoma to study their cytological features. And then
      compared these features with those in their histopathological biopsy or resection.
Hepatic angiosarcoma is a rare hepatic malignant tumor. Although diagnosis of hepatic
      angiosarcoma by FNA cytology has been reported since 1982, followed by several studies, its
      cytomorphologic features were still not well recognized by cytopathologists because of its
      clinical rarity and various morphologic features.

      We reviewed literatures about cytomorphology of hepatic angiosarcoma by FNA. There are only
      11 cases retrieved in 10 articles searched from Medline. The sex M/F ratio was 6/4 (one
      unknown); age range was 56 to 79 years old. In initial cytological evaluation, four cases got
      angiosarcoma or consistent/suspicious angiosarcoma diagnosis. Positive for malignancy,
      sarcoma, and poorly differentiated spindle cell lesion were in one case respectively. One was
      diagnosed as atypical cells. Remaining three were unavailable by their reports.

      In cytological morphologic features, all but one met least 2 of 3 cytological cellular
      criteria of angiosarcoma cells: spindle cells, epithelioid cells, and pleomorphic cells. In
      cytological architectural features, 7 of 11 cases showed vasoformative structures; 5 of 11
      cases showed intracytoplasmic lumen or erythrophagocytosis. Ten of 11 cases had
      histologic/pathologic confirmation as angiosarcoma. One case reported interrelation of tumor
      structures and their own accompanied liver tissue in cell blocks.
observational model: Case-Only
time perspective: Retrospective
measure: all cause mortality
time frame: about 10 years from the date of diagnosis to the last follow-up date by medical record
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
last name: Wern-Cherng Cheng, MD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hemangiosarcoma
sharing ipd: Undecided