UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018489 |
|---|---|
| Receipt number | R000021397 |
| Scientific Title | Genetic analysis of genetic blistering disease |
| Date of disclosure of the study information | 2015/08/10 |
| Last modified on | 2024/02/05 13:37:54 |
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Basic information
Public title
Genetic analysis of genetic blistering disease
Acronym
Genetic analysis of genetic blistering disease
Scientific Title
Genetic analysis of genetic blistering disease
Scientific Title:Acronym
Genetic analysis of genetic blistering disease
Region
| Japan |
Condition
Condition
genetic blistering disease
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To collect genetic samples from patients and identify mutation.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of gene sequencing
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
take a blood sample (2-10mL) or skin biopsy (1cm2), once.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A person who diagnosed genetic blistering disease and his blood relatives
Key exclusion criteria
not applicable
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Masuda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of dermatology
Zip code
Address
Kyoto Prefectural University of Medicine, Kawaramachi Hirokoji, Kamigyo-ku
TEL
075-251-5586
massan@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Masuda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of dermatology
Zip code
Address
Kyoto Prefectural University of Medicine, Kawaramachi Hirokoji, Kamigyo-ku
TEL
075-251-5586
Homepage URL
massan@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of dermatology, Kyoto Prefectural University 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
Address
Tel
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
| 2015 | Year | 08 | Month | 10 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021397
