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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018489
Receipt No. R000021397
Scientific Title Genetic analysis of genetic blistering disease
Date of disclosure of the study information 2015/08/10
Last modified on 2015/08/10

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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
Email 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
Email massan@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2012 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 30 Day
Last modified on
2015 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021397

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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