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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022934
Receipt No. R000026434
Scientific Title Usefulness of new antibody detection in patients with IgG4 related disease ~ prospective study
Date of disclosure of the study information 2016/09/01
Last modified on 2016/06/28

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Basic information
Public title Usefulness of new antibody detection in patients with IgG4 related disease ~ prospective study
Acronym New antibody analysis in patients with IgG4 related disease
Scientific Title Usefulness of new antibody detection in patients with IgG4 related disease ~ prospective study
Scientific Title:Acronym New antibody analysis in patients with IgG4 related disease
Region
Japan

Condition
Condition IgG4 related disease
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Cardiology
Pneumology Endocrinology and Metabolism Nephrology
Clinical immunology Ophthalmology Dermatology
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyse usefulness of new antibody detection in patients with IgG4 related disease for diagnosis and diseas activity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes analysisng sensitivity and specificity to diagnose IgG4 related 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
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the patients fullfilig japanese criteria of IgG4 related disease, autoimmune pancreatitis, IgG4 related sclerosing cholangitis, IgG4 related kidney disease, and IgG4 related lacrimial/orbital disease
Key exclusion criteria under 20 year old or patients who did not agree written consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kodama Yuzo
Organization Kyoto university
Division name gastroenterology and hepatology
Zip code
Address kyoto prefacture kyoto city shogoin kawahara town 54
TEL 075-751-4319
Email kodamayu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiokawa Masahiro
Organization Kyoto university
Division name gastroenterology and hepatology
Zip code
Address kyoto prefacture kyoto city shogoin kawahara town 54
TEL 075-751-4319
Homepage URL
Email machan@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto university
gastroenterology and hepatology
Institute
Department

Funding Source
Organization Kyoto university
gastroenterology and hepatology
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
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
2016 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information to analyse usefullness of new antibody detection at diagnosis, during follow up, and at relapse of IgG4 related disease

Management information
Registered date
2016 Year 06 Month 28 Day
Last modified on
2016 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026434

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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