<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/NCT03288662</url>
  </required_header>
  <id_info>
    <org_study_id>LAnh</org_study_id>
    <nct_id>NCT03288662</nct_id>
  </id_info>
  <brief_title>Relationship Between Computed Tomography Manifestation and Histopathological Classification of Thymic Epithelial Tumors</brief_title>
  <official_title>Evaluate the Relationship Between Computed Tomography Manifestation and Histopathological Classification of Thymic Epithelial Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Military Hospital 103</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nguyen Truong Giang</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Military Hospital 103</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 World Health Organization (WHO) has proposed a classification of histopathological thymic&#xD;
      tumor and it significance in prognosis. Chest computed tomography (CT) is the most common&#xD;
      method to evaluate thymic epithelial tumors before operation. Therefore, the question is to&#xD;
      predict the histopathological type of thymic epithelial tumors before surgery based on&#xD;
      CT-scan images , to help determine treatment strategy and prognosis. In Vietnam, there are no&#xD;
      published literature on this issue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Introduction: the World Health Organization (WHO) has proposed a classification of&#xD;
           histopathological thymic tumor and it significance in prognosis. Chest computed&#xD;
           tomography (CT) is the most common method to evaluate thymic epithelial tumors before&#xD;
           operation. Therefore, the question is to predict the histopathological type of thymic&#xD;
           epithelial tumors before surgery based on CT-scan images , to help determine treatment&#xD;
           strategy and prognosis. In Vietnam, there are no published literature on this issue.&#xD;
&#xD;
        2. Materials and methods:&#xD;
&#xD;
           2.1. Cross-sectional descriptive study on 53 patients with diagnosed of thymoma by CT&#xD;
           and had postoperative histopathology results as thymic epithelial tumors&#xD;
&#xD;
           2.2. Time and Place: in Departement of CTVS, Military Hospital 103, Vietnam from 10/2013&#xD;
           to 7/2017.&#xD;
&#xD;
           2.3. methods:&#xD;
&#xD;
             -  study in chest CT scan:&#xD;
&#xD;
                  -  Measure the maximun diameter of the tumor&#xD;
&#xD;
                  -  The contour: smooth contour or irregular contour&#xD;
&#xD;
                  -  The shape: round, oval and plaque base on the ratio between long axis and&#xD;
                     short axis of the tumor&#xD;
&#xD;
                  -  Some other characteristics: Degree of enhancement, Level of drug absorbed,&#xD;
                     Calcification, Invasion the local organs and Capsular destruction.&#xD;
&#xD;
             -  Histopathological study: based on the 2004 WHO classification:&#xD;
&#xD;
                  -  Thymoma: type A, AB, B1, B2, B3&#xD;
&#xD;
                  -  Thymic carcinoma&#xD;
&#xD;
             -  Data processing: use software Epi Info 2000.&#xD;
&#xD;
        3. Expectation of results&#xD;
&#xD;
             -  Relationship between the size and histopathological type of thymic epithelial&#xD;
                tumors.&#xD;
&#xD;
             -  Comparison of some characteristics of the tumor on preoperative chest CT scans and&#xD;
                histopathological type of thymic epithelial tumors&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2013</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Cross-sectional descriptive study on 53 patients with diagnosed of thymoma by CT and had postoperative histopathology results as thymic epithelial tumors</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>maximun diameter of the tumor</measure>
    <time_frame>1 month</time_frame>
    <description>Measure the maximun diameter of the tumor in chest CT scan</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Thymoma</condition>
  <arm_group>
    <arm_group_label>CT and histopathological classification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>With each histopathological type of thymic epithelial tumors, we measure the maximun diameter in chest CT scan. Comparison of some characteristics of the tumor on preoperative chest CT scans and histopathological type of thymic epithelial tumors .</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CT and histopathological classification</intervention_name>
    <description>Cross-sectional descriptive study on 53 patients with diagnosed of thymoma by CT and had postoperative histopathology results as thymic epithelial tumors. Base on the characteristics in Chest CT scan in each postoperative histopathology results.</description>
    <arm_group_label>CT and histopathological classification</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All of patient have a chest CT scan pre-operation and a result of thymic epithelial&#xD;
             tumors postoperative histopathology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incomplete or loss the CT and postoperative histopathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>71 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Truong Giang Nguyen, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>VMMU</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Military Hospital 103</investigator_affiliation>
    <investigator_full_name>Le Viet Anh, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Computed tomography</keyword>
  <keyword>thymic epithelial tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thymoma</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/NCT03288662
org study id: LAnh
nct id: NCT03288662
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the World Health Organization (WHO) has proposed a classification of histopathological thymic
      tumor and it significance in prognosis. Chest computed tomography (CT) is the most common
      method to evaluate thymic epithelial tumors before operation. Therefore, the question is to
      predict the histopathological type of thymic epithelial tumors before surgery based on
      CT-scan images , to help determine treatment strategy and prognosis. In Vietnam, there are no
      published literature on this issue.
1. Introduction: the World Health Organization (WHO) has proposed a classification of
           histopathological thymic tumor and it significance in prognosis. Chest computed
           tomography (CT) is the most common method to evaluate thymic epithelial tumors before
           operation. Therefore, the question is to predict the histopathological type of thymic
           epithelial tumors before surgery based on CT-scan images , to help determine treatment
           strategy and prognosis. In Vietnam, there are no published literature on this issue.

        2. Materials and methods:

           2.1. Cross-sectional descriptive study on 53 patients with diagnosed of thymoma by CT
           and had postoperative histopathology results as thymic epithelial tumors

           2.2. Time and Place: in Departement of CTVS, Military Hospital 103, Vietnam from 10/2013
           to 7/2017.

           2.3. methods:

             -  study in chest CT scan:

                  -  Measure the maximun diameter of the tumor

                  -  The contour: smooth contour or irregular contour

                  -  The shape: round, oval and plaque base on the ratio between long axis and
                     short axis of the tumor

                  -  Some other characteristics: Degree of enhancement, Level of drug absorbed,
                     Calcification, Invasion the local organs and Capsular destruction.

             -  Histopathological study: based on the 2004 WHO classification:

                  -  Thymoma: type A, AB, B1, B2, B3

                  -  Thymic carcinoma

             -  Data processing: use software Epi Info 2000.

        3. Expectation of results

             -  Relationship between the size and histopathological type of thymic epithelial
                tumors.

             -  Comparison of some characteristics of the tumor on preoperative chest CT scans and
                histopathological type of thymic epithelial tumors
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Cross-sectional descriptive study on 53 patients with diagnosed of thymoma by CT and had postoperative histopathology results as thymic epithelial tumors
primary purpose: Diagnostic
masking: None (Open Label)
measure: maximun diameter of the tumor
time frame: 1 month
description: Measure the maximun diameter of the tumor in chest CT scan
arm group label: CT and histopathological classification
arm group type: Experimental
description: With each histopathological type of thymic epithelial tumors, we measure the maximun diameter in chest CT scan. Comparison of some characteristics of the tumor on preoperative chest CT scans and histopathological type of thymic epithelial tumors .
intervention type: Other
intervention name: CT and histopathological classification
description: Cross-sectional descriptive study on 53 patients with diagnosed of thymoma by CT and had postoperative histopathology results as thymic epithelial tumors. Base on the characteristics in Chest CT scan in each postoperative histopathology results.
arm group label: CT and histopathological classification
criteria: 
gender: All
minimum age: 21 Years
maximum age: 71 Years
healthy volunteers: No
last name: Truong Giang Nguyen, PhD
role: Study Chair
affiliation: VMMU
responsible party type: Principal Investigator
investigator affiliation: Military Hospital 103
investigator full name: Le Viet Anh, MD
investigator title: Principal Investigator
mesh term: Thymoma
sharing ipd: Undecided