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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028720
Receipt No. R000032869
Scientific Title Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases.
Date of disclosure of the study information 2017/08/18
Last modified on 2017/08/18

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Basic information
Public title Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases.
Acronym Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases.
Scientific Title Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases.
Scientific Title:Acronym Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases.
Region
Japan

Condition
Condition connective tissue disease, healthy volunteers
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of histone modifications of lymphocytes and neutrophils in Behcet's disease, autoinflammatory diseases and connective tissue diseases.
Basic objectives2 Others
Basic objectives -Others The purpose of the present study is to elucidate association between the pathogenic mechanism and histone methylations of peripheral white blood cells in connective tissue diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The level of histone methylation of peripheral white blood cells in patients with connective tissue diseases and healthy volunteers.
Key secondary outcomes The factors regulated by histone methylations.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Blood examination
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients and healthy volunteers at least 20 years old at enrollment

2) Patients and healthy volunteers who have given their written informed consent
Key exclusion criteria 1) Pregnant females
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihide Mimura
Organization Saitama Medical University
Division name Department of Rheumatology and Applied Immunology, Faculty of Medicine
Zip code
Address 38 Morohongo, Moroyama-machi, Iruma, Saitama 350-0495, Japan
TEL 049-276-1462
Email toshim@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihide Mimura
Organization Saitama Medical University
Division name Department of Rheumatology and Applied Immunology, Faculty of Medicine
Zip code
Address 38 Morohongo, Moroyama-machi, Iruma, Saitama 350-0495, Japan
TEL 049-276-1462
Homepage URL
Email toshim@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2017 Year 08 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2013 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 18 Day
Last modified on
2017 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032869

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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