UMIN-CTR Clinical Trial
| Recruitment status | No longer recruiting |
|---|---|
| Unique ID issued by UMIN | UMIN000000614 |
| Receipt number | R000000743 |
| Scientific Title | Phase II Study of Thymomectomy for Thymoma Localized in the Thymus |
| Date of disclosure of the study information | 2007/04/01 |
| Last modified on | 2012/11/18 |
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Basic information
Public title
Phase II Study of Thymomectomy for Thymoma Localized in the Thymus
Acronym
JART02
Scientific Title
Phase II Study of Thymomectomy for Thymoma Localized in the Thymus
Scientific Title:Acronym
JART02
Region
| Japan |
Condition
Condition
thymoma
Classification by specialty
| Pneumology | Neurology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the efficacy of subtotal resection of the thymus for thymoma localized in the thymus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
local recurrence rate in five and ten years after the operation
Key secondary outcomes
survival rate, desease free survival rate, local recurrence rate dependent on WHO classification, local recurrence rate
dependent on the operative procedures, local recurrence rate dependent on tumor diameters, local recurrence rate dependent on gender and age, operative morbidity etc.
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
subtotal resection of the thymus for thymoma
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Clinically diagnosed as thymoma localized in the thymus
2.Tolerable for the operation
3.Negative for anti-acethylcholine receptor binding antibody
4.Patients with informed concent
Key exclusion criteria
1.Other malignant neoplasms
2.Myasthenia gravis
3.Pure red cell aplasia
4.Hypogammaimmunogloblinemia
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Fujii |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Oncology, Immunology and Surgery
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8231
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoki Yano |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Oncology, Immunology and Surgery
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8231
Homepage URL
http://plaza.umin.ac.jp/thymus/
motoki@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Japanese Association for Research on the Thymus
Institute
Department
Personal name
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean "funding agency". Therefore, all clinical trial should have the one.
Funding Source
Organization
Japanese Association for Research on the Thymus
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://plaza.umin.ac.jp/thymus/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2007 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 02 | Month | 20 | Day |
Last modified on
| 2012 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000743
