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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046050
Receipt No. R000052561
Scientific Title A Clinical study using healthy samples for the development of a clinical testing technology
Date of disclosure of the study information 2021/11/15
Last modified on 2021/11/12

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Basic information
Public title A Clinical study using healthy samples for the development of a clinical testing technology
Acronym A Clinical study using healthy samples for the development of a clinical testing technology
Scientific Title A Clinical study using healthy samples for the development of a clinical testing technology
Scientific Title:Acronym A Clinical study using healthy samples for the development of a clinical testing technology
Region
Japan

Condition
Condition healthy subject
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For the development of a clinical testing technology, we will conduct tests and sample collection by blood and urine sampling from healthy adults.
Basic objectives2 Others
Basic objectives -Others None
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Small RNAs
Leukocyte telomere length
Protein markers
Key secondary outcomes -

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Blood collection and urine collection on an empty stomach, fill out a questionnaire at the time of visit
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
69 years-old >=
Gender Male and Female
Key inclusion criteria 1)Men and female 20 or more but less than 70 years-old
Key exclusion criteria 1)Those who are affected by any diseases
2)Those who always take medicines or get treatment regularly.
3)Those who have had a medical examination within a year and have a problem with their health
4)Those with severe allergic symptoms
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Morie
Middle name
Last name Nishiwaki
Organization MiRTeL Co.Ltd
Division name Research & Development Division
Zip code 734-0001
Address 1-2-10 Deshio Minami-ku, Hiroshima city, Hiroshima, Japan
TEL 082-546-9797
Email nishiwaki_morie@mirtel.co.jp

Public contact
Name of contact person
1st name Soichi
Middle name
Last name Yoneda
Organization Mibyou Life Science Inc.
Division name Clinical Trial Division
Zip code 101-0061
Address 5F Tokuei Bldg., Kanda Misaki-cho, Chiyoda-ku, Tokyo, Japan
TEL 03-6256-9600
Homepage URL
Email renraku@mibyou-ls.com

Sponsor
Institute Mibyou Life Science Inc.
Institute
Department

Funding Source
Organization MiRTeL Co.Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mibyou Reserch Square Association
Address 2-18-4 kanda-misakicho chiyoda-ku, Tokyo, Japan
Tel 03-6272-9163
Email renraku@npo-mibyou.com

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 メディカルステーションクリニック

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 15 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 04 Day
Date of IRB
2021 Year 11 Month 04 Day
Anticipated trial start date
2021 Year 11 Month 20 Day
Last follow-up date
2021 Year 12 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 12 Day
Last modified on
2021 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052561

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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