UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032894 |
|---|---|
| Receipt number | R000037507 |
| Scientific Title | Development of biological surface analysis method using real time mass spectrometry |
| Date of disclosure of the study information | 2018/06/07 |
| Last modified on | 2021/03/15 19:59:38 |
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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
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
reimufki@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037507
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
