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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024616
Receipt No. R000028269
Scientific Title Study on the correlation between optical multimodal homeostasis evaluation systems (Neutrophil activity, Phagocytic activity, OxLDL quantification) and the common biochemical parameters in human blood samples
Date of disclosure of the study information 2016/11/02
Last modified on 2018/10/29

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Basic information
Public title Study on the correlation between optical multimodal homeostasis evaluation systems (Neutrophil activity, Phagocytic activity, OxLDL quantification) and the common biochemical parameters in human blood samples
Acronym Study on the correlation between optical multimodal homeostasis evaluation systems and the common biochemical parameters in human blood samples
Scientific Title Study on the correlation between optical multimodal homeostasis evaluation systems (Neutrophil activity, Phagocytic activity, OxLDL quantification) and the common biochemical parameters in human blood samples
Scientific Title:Acronym Study on the correlation between optical multimodal homeostasis evaluation systems and the common biochemical parameters in human blood samples
Region
Japan

Condition
Condition healthy people
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The blood collection for the people who undergo a medical examination. We plan to measure some item by this blood with the new evaluation system, to accumulate the basic data.
Basic objectives2 Others
Basic objectives -Others We make evaluations of correlation with such general biochemical examination value measured at medical examinations, and it is the purpose of verifying the utility of the present system.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Optical multimodal homeostasis evaluation systems (Neutrophil activity, Phagocytic activity, OxLDL quantification)
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 Men and women aged 20 or older who agreed to participate.
Key exclusion criteria some people donated blood more than 400ml within 3 months, or more than 200ml within 1 month.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Inagawa
Organization Control of innate immunity technology research association
Division name Research development
Zip code
Address From KAGAWA,Bio Lab,2217-16 Hayashi-cho, Takamatsu,Kagawa
TEL 087-813-9201
Email PXS07205@nifty.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Hanashiro
Organization Control of innate immunity technology research association
Division name Research development
Zip code
Address From KAGAWA,Bio Lab,2217-16 Hayashi-cho, Takamatsu,Kagawa
TEL 087-813-9201
Homepage URL
Email hanashiro@shizenmeneki.org

Sponsor
Institute Cabinet Office, Government of Japan
Institute
Department

Funding Source
Organization Cabinet Office, Government of Japan
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
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 三宅セントラルパーククリニック(香川県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 02 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study make a comparison multimodal analysis of homeostasis in human by developed system and medical examination for the purpose of verifying the utility of the present system. The participants (500 men and women) aged 20 or older were who undergo a medical examination at central park clinic. The blood collection for the participants. We plan to measure some item by this blood for the participants with the new developed system, to accumulate the basic data.

Management information
Registered date
2016 Year 10 Month 28 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028269

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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