UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024616
Receipt number 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 15:31:32

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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 or person

Institute

Cabinet Office, Government of Japan

Institute

Department

Personal name



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

Value
https://center6.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