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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002827
Receipt No. R000003441
Scientific Title Analysis of innate immunity responses in infectious diseases.
Date of disclosure of the study information 2009/12/07
Last modified on 2014/08/31

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Basic information
Public title Analysis of innate immunity responses in infectious diseases.
Acronym Innate immunity responses in infectious diseases.
Scientific Title Analysis of innate immunity responses in infectious diseases.
Scientific Title:Acronym Innate immunity responses in infectious diseases.
Region
Japan

Condition
Condition To examine the modulation of Toll-like receptor 2 and CD64 on monocytes in various infectious diseases
Classification by specialty
Medicine in general Pneumology Clinical immunology
Infectious disease Laboratory medicine Operative medicine
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of useful biomarkers to excess the severity in infectious diseases
Basic objectives2 Others
Basic objectives -Others Biomarker to discriminate infectious diseases from non-infectious inflammatory diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To excess useful baiomarkers to rapidly predict exacerbation/remission and reccurence/complete cure in infectious diseases
Key secondary outcomes Biomarker to discriminate infectious diseases from non-infectious inflammatory diseases

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
15 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Our study population is patients with various inflammatory disease, from who were Informed consent was obtained in accordance with a protocol approved by the Nagasaki University Ethics Committee, and blood sample from healthy volunteers is taken as control.
Key exclusion criteria Patients in whom 10 mL blood sampling may be have harmful effects. Severe anemia etc.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sigeru Kohno
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Molecular Microbiology and Immunology
Zip code
Address 1-7-1, Sakamoto, Nagasaki, 852-8501, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kakeya
Organization Graduate School of of Biomedical Sciences, Nagasaki University
Division name Department of Molecular Microbiology and Immunology
Zip code
Address 1-7-1, Sakamoto, Nagasaki, Japan
TEL 095-819-7273
Homepage URL
Email kakeya-ngs@umin.ac.jp

Sponsor
Institute Department of ,
Graduate School of Medicine, Nagasaki University, Japan
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Cardiovascular, Respiratory and Metabolic Medicine,
Graduate School of Medicine, Kagoshima University, Japan
Name of secondary funder(s) Department of Advanced Medicine and Development, BML, INC. Saitama, Japan

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 長崎大学病院(長崎県)Graduate School of Medicine, Nagasaki University、鹿児島大学病院 (鹿児島県)Graduate School of Medicine, Kagoshima University

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 07 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
2009 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information TLR2 and CD64 expression level on monocyte may provide an important clinical information in a dissimilar fashion to the conventional inflammatory markers.

Management information
Registered date
2009 Year 12 Month 02 Day
Last modified on
2014 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003441

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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