UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027423 |
|---|---|
| Receipt number | R000031423 |
| Scientific Title | Qualitative and quantitative changes in skin T cells during treatments of skin disorders |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2019/05/23 19:46:39 |
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Basic information
Public title
Qualitative and quantitative changes in skin T cells during treatments of skin disorders
Acronym
Skin disorders and skin T cells
Scientific Title
Qualitative and quantitative changes in skin T cells during treatments of skin disorders
Scientific Title:Acronym
Skin disorders and skin T cells
Region
| Japan |
Condition
Condition
inflammatory skin disorders, allergic skin disorders, collagen disease
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the qualitative and quantitative changes in skin T cells and blood T cells during treatments of skin disorders and to find the specific changes of skin T cells according to treatment modalities.
Basic objectives2
Others
Basic objectives -Others
To reveal the changes of skin T cells before and after treatments
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentages of CCR7+CD62L+ central memory T cells, CCR7+CD62L- migratory memory T cells and CD69+CD103+ resident memory T cells in total T cells in lesional skin, non-lesional skin and blood before and after treatments.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
To collect skin biopsy specimens and blood samples after skin lesion is cleared by any kinds of treatments
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
The skin disorder patients whose skin lesions disappeared after any kinds of treatments and who underwent skin biopsies for the sake of diagnosis before treatments.
Key exclusion criteria
None
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Fujimoto |
Organization
University of Tsukuba
Division name
Division of Medicine, Department of Dermatology
Zip code
305-8575
Address
1-1-1, Tennodai, Tsukuba-shi, Ibaraki, Japan
TEL
029-853-3128
rwatanabe@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | |
| Last name | Watanabe |
Organization
University of Tsukuba
Division name
Division of Medicine, Department of Dermatology
Zip code
305-8575
Address
1-1-1, Tennodai, Tsukuba-shi, Ibaraki, Japan
TEL
029-853-3128
Homepage URL
rwatanabe@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
+81298533128
rwatanabe@md.tsukuba.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
| 2017 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2007 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 21 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031423
| 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 |
