UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017128 |
|---|---|
| Receipt number | R000018601 |
| Scientific Title | Gene expression analysis of IgG4 related disease |
| Date of disclosure of the study information | 2015/04/13 |
| Last modified on | 2020/02/09 16:43:39 |
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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
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
yhori@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018601
