UMIN-CTR Clinical Trial

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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