UMIN-CTR Clinical Trial

Basic information
Public title	Development of biological surface analysis method using real time mass spectrometry
Acronym	biological surface analysis method
Scientific Title	Development of biological surface analysis method using real time mass spectrometry
Scientific Title:Acronym	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	1st name Yoshiki Middle name Last name Yoshiki
Organization	Hamamatsu University School of Medicine
Division name	Department of Molecular Anatomy
Zip code	4313125
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
TEL	053-435-2111
Email	tokura@hama-med.ac.jp

Public contact
Name of contact person	1st name Reimu Middle name Last name Fukui
Organization	Hamamatsu University School of Medicine
Division name	Department of Molecular Anatomy
Zip code	4313125
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
TEL	053-435-2111
Homepage URL
Email	reimufki@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)

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu, Japan
Tel	0534352111
Email	otobe@hama-med.ac.jp

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

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	Terminated
Date of protocol fixation	2017 Year 12 Month 07 Day
Date of IRB	2017 Year 12 Month 05 Day
Anticipated trial start date	2017 Year 12 Month 07 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 06 Day
Last modified on	2021 Year 03 Month 15 Day

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