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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027777
Receipt No. 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

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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
Email 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
Email urushihara-hs@pha.keio.ac.jp

Sponsor
Institute Department of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031826

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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