ThymomaNCT03288662
Relationship Between Computed Tomography Manifestation and Histopathological Classification of Thymic Epithelial Tumors
A study testing CT and histopathological classification in people with Thymoma, run by Military Hospital 103.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 71 years
- Conditions the study is for
- Thymoma
- What is being tested?
- CT and histopathological classification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2013to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of patient have a chest CT scan pre-operation and a result of thymic epithelial tumors postoperative histopathology
Who cannot join
- Incomplete or loss the CT and postoperative histopathology
About this study
Official title: Evaluate the Relationship Between Computed Tomography Manifestation and Histopathological Classification of Thymic Epithelial Tumors
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.
Read the 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
- Conditions
- Thymoma
- Being tested
- CT and histopathological classification
- Keywords
- Computed tomography, thymic epithelial tumors
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT and histopathological classificationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Other: CT and histopathological classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximun diameter of the tumor
Measure the maximun diameter of the tumor in chest CT scan
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 Oct 2013
- Primary completion1 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThymomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Hospital 103
- Sponsor type
- University, hospital or other
- Collaborators
- Nguyen Truong Giang
- Responsible party
- Principal investigator, Le Viet Anh, MD, Military Hospital 103
- Investigators
- Truong Giang Nguyen, PhD, Study chair, VMMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288662
- Sponsor's protocol ID
- LAnh
- Status last verified
- Sep 2017
- First submitted
- 7 Sep 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Relationship Between Computed Tomography Manifestation and Histopathological Classification of Thymic Epithelial Tumors
- ClinicalTrials.gov ID
- NCT03288662
- Acronym / sponsor ID
- LAnh
- Conditions
- Thymoma
- Keywords
- Computed tomography, thymic epithelial tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Military Hospital 103University, hospital or other
- Collaborators
- Nguyen Truong Giang
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross-sectional descriptive study on 53 patients with diagnosed of thymoma by CT and had postoperative histopathology results as thymic epithelial tumors
| Arm | Type | Receives |
|---|---|---|
| CT and histopathological classification | Experimental | Other: CT and histopathological classificationWith 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 . |
Who may qualify
- Ages
- 21 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All of patient have a chest CT scan pre-operation and a result of thymic epithelial tumors postoperative histopathology
Key exclusion criteria (1 listed)
- Incomplete or loss the CT and postoperative histopathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT and histopathological classificationCross-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. | Other | CT and histopathological classification |
Primary outcome
maximun diameter of the tumor
Time frame: 1 month
Measure the maximun diameter of the tumor in chest CT scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Thymoma
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Active, not recruitingPhase 1
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma
RecruitingPhase 2
PT-112 in Subjects With Thymoma and Thymic Carcinoma
Thymic Epithelial Tumor, Recurrent Thymoma
Not yet recruitingPhase 2
Phase II Trial of Hypofractionated Radiotherapy Guided by Optical Surface Imaging and Fan-beam CT for Thymoma With Pleural Metastasis
Thymoma and Thymic Carcinoma, Pleural Metastasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Truong Giang Nguyen, PhD study chair
VMMU
Questions about this trial
What is this clinical trial studying?
A study testing CT and histopathological classification in people with Thymoma, run by Military Hospital 103.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximun diameter of the tumor (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.