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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034355
Receipt No. R000039165
Scientific Title Research study on imaging method of skin volatile chemicals using biocatalysis
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/02

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Basic information
Public title Research study on imaging method of skin volatile chemicals using biocatalysis
Acronym Evaluation of imaging system of skin gas
Scientific Title Research study on imaging method of skin volatile chemicals using biocatalysis
Scientific Title:Acronym Evaluation of imaging system of skin gas
Region
Japan

Condition
Condition Healthy people
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To quantatively visulaize model samples, such as alcohol or lipid metabolites, emitted in skin gas for the establishment of a noninvasive evaluation technique of diseases and health status.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Usefulness of the visualization system of skin gas using biocatalysis
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
Food
Interventions/Control_1 Subjects will be asked to drink alcohol or have food in order to visualize samples in skin gas, such as alcohol metabolite.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria A healthy person
Key exclusion criteria - Have a health problem on physical examination
- No good condition on the day
- No experience of drinking alcohol
- Uable to drink alcohol
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohji Mitsubayashi
Organization Tokyo Medical and Dental University
Division name Institute of Biomaterials and Bioengineering
Zip code
Address 2-3-10 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL 03-5280-8091
Email m.bdi@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohji Mitsubayashi
Organization Tokyo Medical and Dental University
Division name Institute of Biomaterials and Bioengineering
Zip code
Address 2-3-10 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL 03-5280-8091
Homepage URL
Email m.bdi@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 11 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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

Management information
Registered date
2018 Year 10 Month 02 Day
Last modified on
2018 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039165

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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