UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012379 |
|---|---|
| Receipt number | 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 13:13:27 |
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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
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
ishigats@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine, Department of Internal Medicine and Clinical Immunology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014463
