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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000743