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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042944
Receipt No. R000048562
Scientific Title The immunological analyses of human peripheral blood mononuclear cells.
Date of disclosure of the study information 2021/01/10
Last modified on 2021/01/08

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Basic information
Public title The immunological analyses of human blood cells.
Acronym The analyses of human blood cells.
Scientific Title The immunological analyses of human peripheral blood mononuclear cells.
Scientific Title:Acronym The analyses of human peripheral blood mononuclear cells.
Region
Japan

Condition
Condition Healthy donners
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is to investigate the immune response of human peripheral blood mononuclear cells. Cells are subjected to protein expression analyses, gene expression analyses, epigenetic analyses, and in vitro culture experiments.
Basic objectives2 Others
Basic objectives -Others Immunology research
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The analyses of gene expression, protein expression, and epigenetic modifications.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Persons who do not have any diseases which require treatments.
Key exclusion criteria Persons who have diseases.
Persons who drowned blood within two weeks.
Persons who do not agree with this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Nakajima
Organization Chiba University Graduate School of Medicine
Division name Department of Allergy and Clinical Immunology
Zip code 260-8670
Address 1-8-1 Inohoana, Chuo-ku, Chiba, Chiba
TEL 043-226-2198
Email nakajimh@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Shigeru
Middle name
Last name Tanaka
Organization Chiba University Graduate School of Medicine
Division name Department of Allergy and Clinical Immunology
Zip code 260-8670
Address 1-8-1 Inohoana, Chuo-ku, Chiba, Chiba
TEL 043-226-2198
Homepage URL
Email stanaka@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Ministray of Education, Culture, Sports, Science and Technology
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 Chiba University Graduate School of Medicine, Ethics Committe
Address 1-8-1 Inohoana, Chuo-ku, Chiba, Chiba
Tel 043-226-2462
Email inohana-rinri@chiba-u.jp

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
2021 Year 01 Month 10 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 Preinitiation
Date of protocol fixation
2021 Year 01 Month 10 Day
Date of IRB
2021 Year 01 Month 04 Day
Anticipated trial start date
2021 Year 01 Month 11 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information this study aim to analyze PBMC from healthy donners.

Management information
Registered date
2021 Year 01 Month 08 Day
Last modified on
2021 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048562

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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