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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017128
Receipt No. R000018601
Scientific Title Gene expression analysis of IgG4 related disease
Date of disclosure of the study information 2015/04/13
Last modified on 2018/10/15

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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 Open public recruiting
Date of protocol fixation
2014 Year 10 Month 02 Day
Date of IRB
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
2018 Year 10 Month 15 Day


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

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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