UMIN-CTR Clinical Trial

Basic information
Public title	Gene expression analysis of IgG4 related disease
Acronym	Gene expression analysis of IgG4 related disease
Scientific Title	Gene expression analysis of IgG4 related disease
Scientific Title:Acronym	Gene expression analysis of IgG4 related disease
Region	Japan

Condition
Condition	IgG4-related disease
Classification by specialty	Hepato-biliary-pancreatic medicine Oto-rhino-laryngology Oral surgery
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate gene expression of IgG4-related disease, which affects molecular mechanism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of disease activity related gene.
Key secondary outcomes	Evaluate gene expression which responds to steroid therapy and recurrence.

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, who consent to participate in the study in Nagoya City University Hospital and research cooperation facilities
Key exclusion criteria	Not obtained the consent
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuki Hori
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Zip code
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL	+81-52-853-8211
Email	yhori@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuki Hori
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Zip code
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL	+81-52-853-8211
Homepage URL
Email	yhori@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagoya Daini Red cross Hospital, Gifu Prefectural Tajimi Hospital, Kasugai Municipal Hospital, Nagoya City West Medical Center
Name of secondary funder(s)	None

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	2015 Year 04 Month 13 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	Terminated
Date of protocol fixation	2014 Year 10 Month 02 Day
Date of IRB	2014 Year 10 Month 02 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other

Other related information

Samples are collected from subjects who participated in this study in Nagoya City University Hospital and research affiliated facilities. Samples and clinical information without containing personal information are numbered and managed in Nagoya City University Hospital. This study is a case control study. From April 2008 to December 2015, consecutive cases are enrolled who diagnosed as pancreatic solid mass and preformed EUS-FNA.

Management information
Registered date	2015 Year 04 Month 13 Day
Last modified on	2020 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018601