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 | 2024/10/22 09:08:44 |
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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
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
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
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
| 2025 | 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
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041637
