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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000614
Receipt No. 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.

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

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
Email

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/
Email motoki@med.nagoya-cu.ac.jp

Sponsor
Institute Japanese Association for Research on the Thymus
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000743

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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