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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039480
Receipt No. R000045015
Scientific Title TOMORROW registry for IgG4-related disease
Date of disclosure of the study information 2020/02/14
Last modified on 2020/02/14

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Basic information
Public title Development of patient database for IgG4-related disease, and analysis of clinical data and samples
Acronym Database for IgG4-related disease, TOMORROW registry
Scientific Title TOMORROW registry for IgG4-related disease
Scientific Title:Acronym TOMORROW registry for IgG4-related disease
Region
Japan

Condition
Condition IgG4-related disease
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Nephrology Clinical immunology
Ophthalmology Oto-rhino-laryngology Urology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To establish a database for IgG4-related disease and resolve clinical unmet needs in the practice
Basic objectives2 Others
Basic objectives -Others To explore novel treatment for precision medicine
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To establish a database for IgG4-related disease and resolve clinical unmet needs in the practice
Key secondary outcomes

Base
Study type Observational

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 patients with IgG4-related disease, diagnosed by the diagnostic criteria for IgG4-related disease, 2011
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Motohisa
Middle name
Last name YAMAMOTO
Organization The Institute of Medical Science, The University of Tokyo
Division name Division of Rheumatology, Center for Vaccine and Antibody, IMSUT Hospital
Zip code 108-8639
Address 4-6-1, Shirokanedai, Minato-ku, Tokyo
TEL 03-3443-8111
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 Division of Rheumatology, Center for Vaccine and Antibody, IMSUT Hospital
Zip code 108-8639
Address 4-6-1, Shirokanedai, Minato-ku, Tokyo
TEL 03-3443-8111
Homepage URL
Email mocha@ims.u-tokyo.ac.jp

Sponsor
Institute The Institute of Medical Science, The University of Tokyo
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Office of Reseach Ethics, The Institute of Medical Science, The University of Tokyo
Address 4-6-1, Shirokanedai, Minato-ku, Tokyo
Tel 03-3443-8111
Email ken-rin@ims.u-tokyo.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
2020 Year 02 Month 14 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 Open public recruiting
Date of protocol fixation
2019 Year 04 Month 09 Day
Date of IRB
2019 Year 07 Month 05 Day
Anticipated trial start date
2019 Year 07 Month 06 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recruitment period may be extended

Management information
Registered date
2020 Year 02 Month 14 Day
Last modified on
2020 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045015

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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