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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034620
Receipt No. R000039475
Scientific Title Introduction of stage classification and promotion of personalized medicine in IgG4-related diseases
Date of disclosure of the study information 2018/10/24
Last modified on 2018/10/24

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Basic information
Public title Introduction of stage classification and promotion of personalized medicine in IgG4-related diseases
Acronym Introduction of stage classification in IgG4-related diseases
Scientific Title Introduction of stage classification and promotion of personalized medicine in IgG4-related diseases
Scientific Title:Acronym Introduction of stage classification in IgG4-related diseases
Region
Japan

Condition
Condition IgG4-related disease
Classification by specialty
Medicine in general Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the personalized treatment for IgG4-related disease with the introduction of staging
Basic objectives2 Others
Basic objectives -Others Analyzing staging classification in IgG4-related disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analyzing the each serum cytokine concentration and the expression of cytokine mRNA in the involved organs
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, who are over 20 years old
Key exclusion criteria None
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohisa Yamamoto
Organization Sapporo Medical University School of Medicine
Division name Department of Rheumatology and Clinical Immunology
Zip code
Address South 1-West 16, Chuo-ku, Sapporo
TEL 011-611-2111
Email mocha@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motohisa Yamamoto
Organization Sapporo Medical University School of Medicine
Division name Department of Rheumatology and Clinical Immunology
Zip code
Address South 1-West 16, Chuo-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email mocha@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2018 Year 10 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2018 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 13 Day
Last follow-up date
2021 Year 03 Month 01 Day
Date of closure to data entry
2021 Year 03 Month 01 Day
Date trial data considered complete
2021 Year 03 Month 01 Day
Date analysis concluded
2021 Year 03 Month 01 Day

Other
Other related information Collection of the cases

Management information
Registered date
2018 Year 10 Month 24 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039475

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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