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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012379
Receipt No. R000014463
Scientific Title Functional analysis of macrophage and natural killer cells in inflammatory and hematologic diseases
Date of disclosure of the study information 2013/11/21
Last modified on 2021/05/28

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Basic information
Public title Functional analysis of macrophage and natural killer cells in inflammatory and hematologic diseases
Acronym Functions of macrophage and NK cells in inflammatory diseases
Scientific Title Functional analysis of macrophage and natural killer cells in inflammatory and hematologic diseases
Scientific Title:Acronym Functions of macrophage and NK cells in inflammatory diseases
Region
Japan

Condition
Condition rheumatoid arthritis, systemic lupus erythermatosus, Behcet's disease, adult-onset Still's disease, other rheumatic disease, hemophagocytosis, hematologic cancer, healthy volunteers
Classification by specialty
Medicine in general Hematology and clinical oncology Clinical immunology
Adult Child
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify relationship between macrophages and NK cells in the pathogenesis of inflammatory and hematologic diseases for the purpose of establishing new treatments.
Basic objectives2 Others
Basic objectives -Others Basic research
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between macrophage and NK cell function and clinical characteristics
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inflammatory and hematologic diseases fulfilling diagnostic criteria
Key exclusion criteria Inflammatory and hematologic diseases not fulfilling diagnostic criteria
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ishigatsubo Yoshiaki
Organization Yokohama City University Graduate School of Medicine
Division name Department of Internal Medicine and Clinical Immunology
Zip code
Address 3-9 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2630
Email kirino@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Ishigatsubo
Organization Yokohama City University Graduate School of Medicine
Division name Department of Internal Medicine and Clinical Immunology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2630
Homepage URL
Email ishigats@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine, Department of Internal Medicine and Clinical Immunology
Institute
Department

Funding Source
Organization The Naito Foundation
Yokohama Medical Foundation for Advancement of Medical Science
Organization
Division
Category of Funding Organization Non profit foundation
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 横浜市立大学附属病院(神奈川県) Yokohama City University Hospital (Kanagawa)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 21 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
2013 Year 11 Month 08 Day
Date of IRB
2013 Year 11 Month 08 Day
Anticipated trial start date
2013 Year 11 Month 19 Day
Last follow-up date
2021 Year 05 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 21 Day
Last modified on
2021 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014463

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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