UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003806 |
|---|---|
| Receipt number | R000004178 |
| Scientific Title | Th1 related molecule in Behcet's disease |
| Date of disclosure of the study information | 2010/06/23 |
| Last modified on | 2019/12/30 14:01:08 |
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Basic information
Public title
Th1 related molecule in Behcet's disease
Acronym
Behcet's disease and Th1 molecule
Scientific Title
Th1 related molecule in Behcet's disease
Scientific Title:Acronym
Behcet's disease and Th1 molecule
Region
| Japan |
Condition
Condition
Behcet's disease
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study has designed to investigate the role of Th1/Th17 related cytokines and signal molecules in Behcet's disease.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
New analysis to the pathogenesis of Behcet's disease from the view of Th1/Th17 cells
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients fulfilled the diagnostic criteria proposed by the International Study Group.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University School of Medicine
Division name
Department of Immunology and Medicine
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
TEL
044-977-8111
n3suzuki@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Shimizu |
Organization
St. Marianna University School of Medicine
Division name
Department of Immunology and Medicine
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
TEL
044-977-8111
Homepage URL
jshimizu@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MHLW (Japan)
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
St. Marianna University School of Medicine
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
| 2010 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2005 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will observe Th1 and Th17 responces in peripheral blood mononuclear cells or tissues with Behcet disease. Case control sampling.
Management information
Registered date
| 2010 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004178
