search
Back to results

Relationship Between Computed Tomography Manifestation and Histopathological Classification of Thymic Epithelial Tumors

Primary Purpose

Thymoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CT and histopathological classification
Sponsored by
Military Hospital 103
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thymoma focused on measuring Computed tomography, thymic epithelial tumors

Eligibility Criteria

21 Years - 71 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All of patient have a chest CT scan pre-operation and a result of thymic epithelial tumors postoperative histopathology

Exclusion Criteria:

  • Incomplete or loss the CT and postoperative histopathology

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CT and histopathological classification

    Arm 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 .

    Outcomes

    Primary Outcome Measures

    maximun diameter of the tumor
    Measure the maximun diameter of the tumor in chest CT scan

    Secondary Outcome Measures

    Full Information

    First Posted
    September 7, 2017
    Last Updated
    September 19, 2017
    Sponsor
    Military Hospital 103
    Collaborators
    Nguyen Truong Giang
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03288662
    Brief Title
    Relationship Between Computed Tomography Manifestation and Histopathological Classification of Thymic Epithelial Tumors
    Official Title
    Evaluate the Relationship Between Computed Tomography Manifestation and Histopathological Classification of Thymic Epithelial Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2013 (Actual)
    Primary Completion Date
    July 1, 2017 (Actual)
    Study Completion Date
    July 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Military Hospital 103
    Collaborators
    Nguyen Truong Giang

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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. 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. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thymoma
    Keywords
    Computed tomography, thymic epithelial tumors

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Cross-sectional descriptive study on 53 patients with diagnosed of thymoma by CT and had postoperative histopathology results as thymic epithelial tumors
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CT and histopathological classification
    Arm Type
    Experimental
    Arm 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(s)
    CT and histopathological classification
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    maximun diameter of the tumor
    Description
    Measure the maximun diameter of the tumor in chest CT scan
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    71 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All of patient have a chest CT scan pre-operation and a result of thymic epithelial tumors postoperative histopathology Exclusion Criteria: Incomplete or loss the CT and postoperative histopathology
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Truong Giang Nguyen, PhD
    Organizational Affiliation
    VMMU
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Relationship Between Computed Tomography Manifestation and Histopathological Classification of Thymic Epithelial Tumors

    We'll reach out to this number within 24 hrs