UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000015945
Receipt No. 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 (Ver. 5)

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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
Email 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
Email shin-ya@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018494