UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009851 |
|---|---|
| Receipt number | R000011542 |
| Scientific Title | Development of the genetic diagnosis system of congenital and Inherited skin disorders |
| Date of disclosure of the study information | 2013/01/25 |
| Last modified on | 2024/08/01 10:20:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of the genetic diagnosis system of congenital and Inherited skin disorders
Acronym
Development of the genetic diagnosis system of congenital and Inherited skin disorders
Scientific Title
Development of the genetic diagnosis system of congenital and Inherited skin disorders
Scientific Title:Acronym
Development of the genetic diagnosis system of congenital and Inherited skin disorders
Region
| Japan | Asia(except Japan) |
Condition
Condition
congenital and Inherited skin disorders
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To develop a genetic diagnosis system for congenital and Inherited skin disorders using next generation sequencers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
By this method, we can analyze multiple gene mutations by a single analysis.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Having skin diseases that could be congenital or inherited
Key exclusion criteria
Having non-congenital skin disorder
Target sample size
8050
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ito |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
yoshihiro.ito@keio.jp
Public contact
Name of contact person
| 1st name | Akiharu |
| Middle name | |
| Last name | Kubo |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
akiharukubo@gmail.com
Sponsor or person
Institute
Department of Dermatology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Dermatology, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Child Health and Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Hospital
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
03-5363-3503
akihiro.mitsunaga@adst.keio.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
旭川医科大学医学部皮膚科学講座
北海道大学病院皮膚科
慶應義塾大学医学部附属病院
国立成育医療研究センター
東京医科大学病院皮膚科
東邦大学医療センター大森病院皮膚科
帝京大学医学部附属病院皮膚科
けいゆう病院皮膚科
群馬大学医学部附属病院皮膚科
平塚市民病院皮膚科
株式会社日立製作所日立総合病院皮膚科
獨協医科大学埼玉医療センター皮膚科
獨協医科大学医学部皮膚科
日野市立病院皮膚科
浜松医科大学医学部附属病院皮膚科
福井大学医学部附属病院皮膚科
富山大学医学部附属病院皮膚科
富士宮市立病院皮膚科
静岡県立総合病院皮膚科
新潟大学医歯学総合病院皮膚科
岐阜大学医学部附属病院皮膚科
信州大学医学部附属病院皮膚科
石川県立中央病院皮膚科
三重大学医学部皮膚科
京都大学医学部附属病院
神戸大学医学部附属病院皮膚科
大阪市立大学医学部附属病院皮膚科
加古川中央市民病院皮膚科
兵庫県立淡路医療センター皮膚科
兵庫県立加古川医療センター皮膚科
川崎医科大学附属病院皮膚科
川崎医科大学総合医療センター皮膚科
四国こどもとおとなの医療センター
高知大学医学部附属病院皮膚科
香川大学医学部附属病院皮膚科
産業医科大学病院皮膚科
大分大学医学部附属病院皮膚科
福岡市立こども病院皮膚科
Quy Hoa National Leprosy Dermatology Hospital (ベトナム)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We identified that mutations in SERPINB7 cause Nagashima-type palmoplantar keratosis.
Results date posted
| 2020 | Year | 01 | Month | 29 | Day |
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
| 2013 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The research was subsequently taken over by a successor research project, entitled "Research to elucidate pathological conditions of skin diseases caused by genetic alterations by multi-omics analysis.
Management information
Registered date
| 2013 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011542
