UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034624
Receipt number R000039477
Scientific Title The studies for establish the diagnostic criteria and treatment guideline for IgG4-related disease
Date of disclosure of the study information 2018/10/24
Last modified on 2024/02/16 10:18:14

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Basic information

Public title

The studies for establish the diagnostic criteria and treatment guideline for IgG4-related disease

Acronym

Establish the diagnostic criteria and treatment guideline for IgG4-related disease

Scientific Title

The studies for establish the diagnostic criteria and treatment guideline for IgG4-related disease

Scientific Title:Acronym

Establish the diagnostic criteria and treatment guideline for IgG4-related disease

Region

Japan


Condition

Condition

IgG4-related disease

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine Cardiology
Pneumology Nephrology Clinical immunology
Ophthalmology Oto-rhino-laryngology Urology
Oral surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To establish the diagnostic criteria and treatment guideline for IgG4-related disease

Basic objectives2

Others

Basic objectives -Others

To establish the diagnostic criteria and treatment guideline for IgG4-related disease

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To establish the diagnostic criteria and treatment guideline for IgG4-related disease

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The cases with IgG4-related disease, who are over 20 years old

Key exclusion criteria

None

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Mitsuhiro
Middle name
Last name KAWANO

Organization

Kanazawa Medical University

Division name

Department of Hematology and Rheumatology

Zip code

920-0293

Address

1-1, Daigaku, Uchinada-cho, Kahoku-gun, Ishikawa

TEL

076-286-2211

Email

mocha@ims.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Motohisa
Middle name
Last name YAMAMOTO

Organization

The Institute of Medical Science, The University of Tokyo

Division name

Department of Rheumatology and Allergy, IMSUT Hospital

Zip code

1088639

Address

4-6-1, Shirokanedai, Mitnato-ku, Tokyo

TEL

03-3443-8111

Homepage URL


Email

mocha@ims.u-tokyo.ac.jp


Sponsor or person

Institute

Ministry of Health, Labour and Welfare

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshidakonoemachi, Sakyo-ku, Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp


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

2018 Year 10 Month 24 Day


Related information

URL releasing protocol


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

Enrolling by invitation

Date of protocol fixation

2017 Year 01 Month 15 Day

Date of IRB

2017 Year 02 Month 10 Day

Anticipated trial start date

2017 Year 02 Month 10 Day

Last follow-up date

2020 Year 03 Month 01 Day

Date of closure to data entry

2020 Year 03 Month 01 Day

Date trial data considered complete

2020 Year 03 Month 01 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information

Collection of the cases


Management information

Registered date

2018 Year 10 Month 24 Day

Last modified on

2024 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039477


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name