UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012977
Receipt No. R000015125
Scientific Title Clinical study using human blood and PBMCs about IgG4-related disease.
Date of disclosure of the study information 2014/01/31
Last modified on 2015/09/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical study using human blood and PBMCs about IgG4-related disease.
Acronym Clinical study using human blood and PBMCs about IgG4-related disease.
Scientific Title Clinical study using human blood and PBMCs about IgG4-related disease.
Scientific Title:Acronym Clinical study using human blood and PBMCs about IgG4-related disease.
Region
Japan

Condition
Condition IgG4-related disease
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Functional analysis and expression analysis of microRNA using Blood and PBMCs from IgG4-related disease patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Flow cytometry analysis(FACS),various stimulation test of PBMCs from each patients groups(IgG4-related disease patients ,healthy volunteer, Castleman's disease, ANCA associated vasculitis and Sjögren's syndrome),and expression analysis of microRNA in the sample .
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria IgG4-related disease patients, control group patients (Castleman's disease, ANCA associated vasculitis , and Sjögren's syndrome),and healthy volunteer,who consent to participate in the study in Hyogo College of Medicine and eleven research cooperation facilities
Key exclusion criteria Not obtained the consent
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Ishii
Organization National Institutes of Biomedical Innovation,Health and Nutrition
Division name Laboratory of Adjuvant Innovation
Zip code
Address 7-6-8 Asagi Saito Ibaraki-City Osaka
TEL 072-641-8043
Email kenishii@biken.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Ishii
Organization National Institutes of Biomedical Innovation,Health and Nutrition
Division name Laboratory of Adjuvant Innovation
Zip code
Address 7-6-8 Asagi Saito Ibaraki-City Osaka
TEL 072-641-8043
Homepage URL
Email kenishii@biken.osaka-u.ac.jp

Sponsor
Institute National Institutes of Biomedical Innovation,Health and Nutrition
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Hyogo College of Medicine
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
2014 Year 01 Month 31 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 Completed
Date of protocol fixation
2012 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 10 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 Samples are collected from subjects who consent to participate in this study in Hyogo College of Medicine and eleven research cooperation facilities.
Then samples and clinical information not containing personal information are only numbered and transported to National Institute of Biomedical Innovation.

Management information
Registered date
2014 Year 01 Month 27 Day
Last modified on
2015 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015125

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.