UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021022 |
|---|---|
| Receipt number | R000024220 |
| Scientific Title | Investigation of the pathogenesis of autoimmune vitiligo and the regulatory mechanism of HLA-A expression |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2021/02/17 22:05:29 |
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Basic information
Public title
Investigation of the pathogenesis of autoimmune vitiligo and the regulatory mechanism of HLA-A expression
Acronym
Investigation of the pathogenesis of autoimmune vitiligo and the regulatory mechanism of HLA-A expression
Scientific Title
Investigation of the pathogenesis of autoimmune vitiligo and the regulatory mechanism of HLA-A expression
Scientific Title:Acronym
Investigation of the pathogenesis of autoimmune vitiligo and the regulatory mechanism of HLA-A expression
Region
| Japan |
Condition
Condition
Vitiligo vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to clarify the pathogenesis of vitiligo vulgaris and regulatory mechanism of HLA-A expression using molecular biology techniques.
Basic objectives2
Others
Basic objectives -Others
This study aims to clarify the pathogenesis of vitiligo vulgaris and regulatory mechanism of HLA-A expression using molecular biology techniques.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement of HLA-A mRNA and the activity of HLA-A regularoty region using peripheral blood of Japanese volunteers.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Gene |
Interventions/Control_1
The peripheral blood is taken from Japanese volunteers. Genomic DNA is extracted from blood and significant SNPs for vitiligo risk are genotyped. The volunteers are classified into two groups, and subsequently their HLA-A mRNA is measured.
This group is high risk.
Interventions/Control_2
This group is non-high risk.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
No specific condition is needed.
Key exclusion criteria
No specific exclusion is needed.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Hayashi |
Organization
Yamagata University School of Medicine
Division name
Department of Dermatology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata
TEL
023-628-5361
czk11223@nifty.ne.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Hayashi |
Organization
Yamagata University School of Medicine
Division name
Department of Dermatology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata
TEL
023-628-5361
Homepage URL
czk11223@nifty.ne.jp
Sponsor or person
Institute
Yamagata University School of Medicine, Department of Dermatology
Institute
Department
Personal name
Funding Source
Organization
Ministry of education and science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2 Iida-Nishi, Yamagata
Tel
023-628-5047
ikekenkyu@jm.kj.yamagata-u.ac.jp
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
山形大学医学部
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
| Delay expected |
Results Delay Reason
The time to analyze the data was longer than we initially anticipated.
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
None.
Management information
Registered date
| 2016 | Year | 02 | Month | 14 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024220
