UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036546
Receipt number R000041637
Scientific Title Development for health biomarker in Healthy subjects
Date of disclosure of the study information 2019/05/01
Last modified on 2023/04/24 10:50:21

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Basic information

Public title

Development for health biomarker in Healthy subjects

Acronym

Development for health biomarker

Scientific Title

Development for health biomarker in Healthy subjects

Scientific Title:Acronym

Development for health biomarker

Region

Japan


Condition

Condition

healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

development for healthy biomarker

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

decided in normal range of the biomarker

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

65 years-old >

Gender

Male and Female

Key inclusion criteria

Health Adult subject

Key exclusion criteria

Serious illnesses, Mental disease
Anemia
Judgement by medical doctor

Target sample size

2500


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Toyozawa

Organization

Medical Corporation Sowakai

Division name

Medical Center

Zip code

252-0232

Address

4-10-13, Yabe, Chuou-Ku, Sagamihara-Shi, Kanagawa, Japan

TEL

042-756-2666

Email

sanken@sowa.or.jp


Public contact

Name of contact person

1st name Ryosuke
Middle name
Last name Matsuoka

Organization

Kewpie Corporation

Division name

R&D Division

Zip code

182-0002

Address

2-5-7 Sengawa Kewport, Sengawa-cho, Chofu-Shi, Tokyo, Japan

TEL

03-5384-7759

Homepage URL


Email

ryosuke_matsuoka@kewpie.co.jp


Sponsor or person

Institute

Kewpie Corporation

Institute

Department

Personal name



Funding Source

Organization

Kewpie Corporation

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ueno Asagao Clinic Ethics Committee

Address

Kairaku building 6F, 2-5-7 Higashi-ueno, Taito-ku, Tokyo, Japan

Tel

03-6801-8480

Email

t.tamura@tes-h.co.jp


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



Other administrative information

Date of disclosure of the study information

2019 Year 05 Month 01 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

2019 Year 03 Month 30 Day

Date of IRB

2019 Year 04 Month 04 Day

Anticipated trial start date

2019 Year 04 Month 08 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Blood sample was collected from healthy subject, and analysis the biomarker for decision of normal range for healthy subject.


Management information

Registered date

2019 Year 04 Month 19 Day

Last modified on

2023 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041637


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name