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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032894
Receipt No. R000037507
Official scientific title of the study Development of biological surface analysis method using real time mass spectrometry
Date of disclosure of the study information 2018/06/07
Last modified on 2018/06/06

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Basic information
Official scientific title of the study Development of biological surface analysis method using real time mass spectrometry
Title of the study (Brief title) biological surface analysis method
Region
Japan

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

Objectives
Narrative objectives1 This research aims to develop a method for directly measuring the molecules of the skin of the living body using the DESI device, and in the future it aims to clarify the molecular mechanism of inflammation and deterioration such as atopic dermatitis.
We study and develop the measurement conditions (solvent, application, distance, etc.) for detecting biomolecules from the living skin of a healthy person using the DESI device. It also collects the basic data of the living skin of a healthy person.
Basic objectives2 Others
Basic objectives -Others Consideration of measuring equipment
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Conditions for obtaining peak signal.
(Solvent concentration, flow rate of solvent spray, applications, distance between sample and solvent spray port.)
Key secondary outcomes Analyze whether inflammatory lipid mediators such as prostaglandins and leukotrienes are present.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 This biosensor is slightly invasively ionized to obtain a sample.
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
80 years-old >
Gender Male and Female
Key inclusion criteria A healthy person over 20 years old who participates by self-intention
Key exclusion criteria Perform alcohol patch test beforehand and exclude positive subjects.
19 years or younger
During pregnancy / breast-feeding
Skin disease patients
Cancer patient
Target sample size 20

Research contact person
Name of lead principal investigator Yoshiki Tokura
Organization Hamamatsu University School of Medicine
Division name Department of Dermatology
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
TEL 053-435-2303
Email tokura@hama-med.ac.jp

Public contact
Name of contact person Shinsuke Nakazawa
Organization Hamamatsu University School of Medicine
Division name Department of Dermatology
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
TEL 053-435-2303
Homepage URL
Email szawa@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Secondary IDs
Secondary IDs YES
Study ID_1 17-218
Org. issuing International ID_1 Hamamatsu University School of Medicine
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 06 Month 07 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 12 Month 07 Day
Anticipated trial start date
2017 Year 12 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 06 Day
Last modified on
2018 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037507

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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