Relationship Between Computed Tomography Manifestation an... | NCT03288662

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

NCT03288662

Sponsor

Military Hospital 103

Status

Completed

Last Update Posted

Sep 20, 2017Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Thymoma

Interventions

CT and histopathological classification

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2013Actual

Primary Completion Date

Jul 1, 2017Actual

Completion Date

Jul 31, 2017Actual

First Submitted Date

Sep 7, 2017

First Submission Date that Met QC Criteria

Sep 19, 2017

First Posted Date

Sep 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2017

Last Update Posted Date

Sep 20, 2017Actual

Name	Class
Nguyen Truong Giang	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CT and histopathological classification	Experimental	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 .	Other: CT and histopathological classification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT and histopathological classification	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
maximun diameter of the tumor	Measure the maximun diameter of the tumor in chest CT scan	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

71 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Truong Giang Nguyen, PhD	VMMU	Study Chair

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013945	Thymoma

Ancestor Terms

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D013953	Thymus Neoplasms

Browse Leaves

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Browse Branches

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