UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046050 |
|---|---|
| Receipt number | 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 | 2022/01/07 13:57:36 |
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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
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
renraku@mibyou-ls.com
Sponsor or person
Institute
Mibyou Life Science Inc.
Institute
Department
Personal name
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
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
216
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
Completed
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
| 2022 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052561
