UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of new antibody detection in patients with IgG4 related disease ~ prospective study
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kodama Yuzo
Organization	Kyoto university
Division name	gastroenterology and hepatology
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	Shiokawa Masahiro
Organization	Kyoto university
Division name	gastroenterology and hepatology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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