UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006317 |
|---|---|
| Receipt number | R000007483 |
| Scientific Title | Genetic mutational analyses in hereditary skin diseases of minors |
| Date of disclosure of the study information | 2011/10/30 |
| Last modified on | 2015/03/09 14:41:49 |
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Basic information
Public title
Genetic mutational analyses in hereditary skin diseases of minors
Acronym
Genetic analyses in hereditary skin diseases of minors
Scientific Title
Genetic mutational analyses in hereditary skin diseases of minors
Scientific Title:Acronym
Genetic analyses in hereditary skin diseases of minors
Region
| Japan |
Condition
Condition
Hereditary skin disease
Classification by specialty
| Clinical immunology | Pediatrics | Dermatology |
| Oral surgery | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To better understand the cause and pathogenetic mechanism of hereditary skin diseases.
Basic objectives2
Others
Basic objectives -Others
To analyse phenotype/genotype correlation through identification of the causative gene and mutational sites.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Genetic analyses will be completed from the patient's blood sample in several months.
Key secondary outcomes
It will take more months to finish if the first genetic analyses fail to identify the causative gene or mutational site.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
10ml of blood sample is collected by venipuncture
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
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients under the age of 20 with hereditary skin diseases who or whose parent(s) understand the meaning of genetic analyses and give their consent to the study
Key exclusion criteria
Patients under the age of 20 with hereditary skin diseases who or whose parent(s) cannot understand the meaning of genetic analyses nor give their consent to the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Fujimoto |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
Address
Matsushima 577, Kurashiki, Okayama
TEL
086-462-1111
watarufu@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wataru Fujimoto |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
Address
Matsushima 577, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
http://www.kawasaki-m.ac.jp
watarufu@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Dermatology, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
川崎医科大学附属病院(岡山県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 30 | 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
| 2011 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | 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
| 2011 | Year | 09 | Month | 08 | Day |
Last modified on
| 2015 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007483
