UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015945 |
|---|---|
| Receipt number | R000018494 |
| Scientific Title | Multicenter study for discover of useful biomarkers in differential diagnosis and assessment of disease activity in patients with IgG4-related disease |
| Date of disclosure of the study information | 2014/12/15 |
| Last modified on | 2019/12/19 16:10:40 |
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Basic information
Public title
Multicenter study for discover of useful biomarkers in differential diagnosis and assessment of disease activity in patients with IgG4-related disease
Acronym
Study of biomarkers in IgG4-related disease
Scientific Title
Multicenter study for discover of useful biomarkers in differential diagnosis and assessment of disease activity in patients with IgG4-related disease
Scientific Title:Acronym
Study of biomarkers in IgG4-related disease
Region
| Japan |
Condition
Condition
IgG4-related disease
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between diagnosis or disease activity (severity and organ disorder) and biomarkers detected by ELISA methods before and after treatment in patients with IgG4-related disease
Basic objectives2
Others
Basic objectives -Others
Verify the association of diagnosis and disease (severity and organ failure) and biomarkers of IgG4-related disease
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
IgG4 diagnosis of related diseases and disease
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-IgG4-related disease patients(30cases)
-Discrimination is required disease (Castlemans disease,malignant lymphoma,etc.) patients (10 cases)
-Healthy volunteers consent was obtained in our hospital staff (20 cases)
Key exclusion criteria
none
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Kawashiri |
Organization
Nagasaki University Graduate School of Biomedical Sciences All Rights Reserved
Division name
Department of Public Health
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7067
shin-ya@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Kawashiri |
Organization
Nagasaki University Graduate School of Biomedical Sciences All Rights Reserved
Division name
Department of Public Health
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7067
Homepage URL
shin-ya@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2014 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-018-1777-7
Publication of results
Unpublished
Result
URL related to results and publications
https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-018-1777-7
Number of participants that the trial has enrolled
72
Results
https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-018-1777-7
Results date posted
| 2019 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-018-1777-7
Participant flow
https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-018-1777-7
Adverse events
-
Outcome measures
https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-018-1777-7
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 10 | Month | 31 | Day |
Other
Other related information
Discovery research
Management information
Registered date
| 2014 | Year | 12 | Month | 15 | Day |
Last modified on
| 2019 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018494
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
