UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009708 |
|---|---|
| Receipt number | R000011380 |
| Scientific Title | Investigation of drug specific cytotoxic T cell in severe cutaneous adverse drug reaction |
| Date of disclosure of the study information | 2013/01/07 |
| Last modified on | 2014/03/30 01:22:46 |
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Basic information
Public title
Investigation of drug specific cytotoxic T cell in severe cutaneous adverse drug reaction
Acronym
Investigation of drug specific cytotoxic T cell in severe cutaneous adverse drug reaction
Scientific Title
Investigation of drug specific cytotoxic T cell in severe cutaneous adverse drug reaction
Scientific Title:Acronym
Investigation of drug specific cytotoxic T cell in severe cutaneous adverse drug reaction
Region
| Japan |
Condition
Condition
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pathogenic mechanism of severe cutaneous adverse drug reaction
Basic objectives2
Others
Basic objectives -Others
To clarify the pathogenic mechanism of disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Proliferation of drug specific cytotoxic T cell
2. Cytotoxicity of drug specific T cell against cells expressing specific HLA type
3. Cytokine production of drug specific cytotoxic T cell
4. Repertoire of T cell receptor
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Stevens-Johnson syndrome
Interventions/Control_2
Toxic epidermal necrolysis
Interventions/Control_3
Healthy control
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
Patient with Stevens-Johnson syndrome or toxic epidermal necrolysis
Key exclusion criteria
Patient regarded as inadequate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiko Aihara |
Organization
Yokohama City University Graduate School of Medicine
Division name
Environmental-Immuno Dermatology
Zip code
Address
Fukuura 3-9, Kanazawa, Yokohama
TEL
045-787-2675
nabetomo0968@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Watanabe |
Organization
Yokohama City University Graduate School of Medicine
Division name
Environmental Immuno-Dermatology
Zip code
Address
Fukuura 3-9, Kanazawa, Yokohama
TEL
045-787-2675
Homepage URL
nabetomo0968@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Health Sciences
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 07 | 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 | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | 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
| 2013 | Year | 01 | Month | 06 | Day |
Last modified on
| 2014 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011380
| 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 |
