UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017364 |
|---|---|
| Receipt number | R000020150 |
| Scientific Title | Clinical state and stage analysis of atopic dermatitis and psoriasis by Whole blood cytokine release assay |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2021/03/09 17:06:50 |
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Basic information
Public title
Clinical state and stage analysis of atopic dermatitis and psoriasis by Whole blood cytokine release assay
Acronym
Clinical state and stage analysis of atopic dermatitis and psoriasis by Whole blood cytokine release assay
Scientific Title
Clinical state and stage analysis of atopic dermatitis and psoriasis by Whole blood cytokine release assay
Scientific Title:Acronym
Clinical state and stage analysis of atopic dermatitis and psoriasis by Whole blood cytokine release assay
Region
| Japan |
Condition
Condition
Atopic dermatitis, Psoriasis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether results of Whole blood cytokine release assay can predict the drug effect.
Basic objectives2
Others
Basic objectives -Others
evaluation of assay system
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between suppressive ability of the drugs assessed by Whole blood cytokine release assay and clinical effect of the drugs on individual atopic dermatitis or psoriasis patient.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Atopic dermatitis patient, psoriasis patient who undergo at the department of dermatology at Tohoku University Hospital
Key exclusion criteria
patient who is administrated biologics.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Setsuya |
| Middle name | |
| Last name | Aiba |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku,Sendai,Miyagi
TEL
022-717-7271
saiba@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Kimura |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku,Sendai,Miyagi
TEL
022-717-7271
Homepage URL
yutakakimura@m.tohoku.ac.jp
Sponsor or person
Institute
Department of Dermatology
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Tohoku University Graduate School of Medicine
Address
1-1 Seiryo-machi, Aoba-ku,Sendai,Miyagi
Tel
022-717-7145
hospikken@bureau.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
whole blood from 6 healthy volunteer was assessed
Management information
Registered date
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2021 | 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=R000020150
| Research Plan | |
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| 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 |
