UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002827
Receipt number 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 21:03:19

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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