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
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
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
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
