UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027777 |
|---|---|
| Receipt number | R000031826 |
| Scientific Title | Development of algorithms to identify Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Japanese |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2017/11/04 22:15:34 |
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Basic information
Public title
Development of algorithms to identify Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Japanese
Acronym
Development of algorithms to identify SJS and TEN
Scientific Title
Development of algorithms to identify Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Japanese
Scientific Title:Acronym
Development of algorithms to identify SJS and TEN
Region
| Japan |
Condition
Condition
skin disease:
Stevens-Johnson Syndrome(SJS)
Toxic Epidermal Necrolysis(TEN)
Erythema Multiforme major(EM major)
Staphylococcal Scalded Skin Syndrome(SSSS)
Toxicodermia
fixed drug eruption
Drug-induced hypersensitivity syndrome(DIHS)
impetigo contagiosa
Acute Generalized Exanthematous Pustulosis(AGEP)
paraneoplastic pemphigus
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop algorithms to identify SJS and TEN based on electronic medical records. Developed algorithms are applied to a large scale medical information database, to distinguish SJS and TEN from other diseases.
Basic objectives2
Others
Basic objectives -Others
Validity of developed algorithms
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity, specificity and positive predictive value(PPV)
Key secondary outcomes
None
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diseases specified in Condition.
Key exclusion criteria
Patients concomitantly affected with SJS/TEN and DIHS.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Urushihara |
Organization
Faculty of Pharmacy, Keio University
Division name
Department of Drug Development and Regulatory Science
Zip code
Address
1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512 Japan
TEL
03-5400-2649
urushihara-hs@pha.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Urushihara |
Organization
Faculty of Pharmacy, Keio University
Division name
Department of Drug Development and Regulatory Science
Zip code
Address
1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512 Japan
TEL
03-5400-2649
Homepage URL
urushihara-hs@pha.keio.ac.jp
Sponsor or person
Institute
Department of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Dermatology, Faculty of Medicine, Keio University
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | 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
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
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Study design:
Validation study
We use electronic medical records in Keio University Hospital and assess the validity of algorithms to identify incident SJS/TEN patients.
Management information
Registered date
| 2017 | Year | 06 | Month | 16 | Day |
Last modified on
| 2017 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031826
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
