UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034622 |
|---|---|
| Receipt number | R000039473 |
| Scientific Title | Establishment of registry system for IgG4-related disease and analysis of the data and the samples |
| Date of disclosure of the study information | 2018/10/24 |
| Last modified on | 2024/02/16 09:58:45 |
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Basic information
Public title
Establishment of registry system for IgG4-related disease and analysis of the data and the samples
Acronym
Establishment of registry system for IgG4-related disease
Scientific Title
Establishment of registry system for IgG4-related disease and analysis of the data and the samples
Scientific Title:Acronym
Establishment of registry system for IgG4-related disease
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 transmit new clinical information of IgG4-related disease, and clarify the pathogenesis and develop a novel treatment.
Basic objectives2
Others
Basic objectives -Others
Identify the clinical characteristics of IgG4-related disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We perform the analysis of the clinical data and samples every year.
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
2000
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Takahashi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Rheumatology and Clinical Immunology
Zip code
0608543
Address
South 1-West 16, Chuo-ku, Sapporo
TEL
011-611-2111
htakahas@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Motohisa |
| Middle name | |
| Last name | Yamamoto |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Rheumatology and Clinical Immunology
Zip code
0608543
Address
South 1-West 16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
mocha@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Sapporo Medical University Hospital
Address
S1-W16, Chuo-ku, Sapporo
Tel
011-611-2111
ji-rskk@sapmed.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
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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 12 | 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=R000039473
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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