UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028358 |
|---|---|
| Receipt number | R000032466 |
| Scientific Title | Novel identification of collagen disease immune cell subsets |
| Date of disclosure of the study information | 2017/07/25 |
| Last modified on | 2017/07/25 09:08:12 |
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Basic information
Public title
Novel identification of collagen disease immune cell subsets
Acronym
Novel identification of collagen disease immune cell subsets
Scientific Title
Novel identification of collagen disease immune cell subsets
Scientific Title:Acronym
Novel identification of collagen disease immune cell subsets
Region
| Japan |
Condition
Condition
Connective tissue disease
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We confirmed the abnormality of a subset of lymphocytes in various collagen diseases (systemic lupus erythematosus, dermatomyositis, vasculitis syndrome, etc.) as a condition, analyzed its dynamics from the relation with the disease state and pathological condition of the abnormal subset.
Basic objectives2
Others
Basic objectives -Others
Development of new drugs
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of new lymphocyte subsets
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with RA, SLE, IM, vasculitis syndrome, SS, MCTD, SSc before consent acquisition.
Key exclusion criteria
Patients who are considered to be inappropriate for participation in this study due to serious and uncontrollable coexisting diseases (observation / examination) such as coexisting diseases (cardiovascular, nervous system, lung, kidney, liver, endocrine, gastrointestinal etc.)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ishii tomonori |
Organization
tohoku university hospital
Division name
devision of hematology and rheumatology
Zip code
Address
1-1 seiryocho, aobaku
TEL
0227177165
tishii@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ishii tomonori |
Organization
tohoku university hospital
Division name
devision of hematology and rheumatology
Zip code
Address
1-1
TEL
+81227177165
Homepage URL
tishii@med.tohoku.ac.jp
Sponsor or person
Institute
tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
SBI biotech
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2017 | Year | 07 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
anlysis of subset
Management information
Registered date
| 2017 | Year | 07 | Month | 25 | Day |
Last modified on
| 2017 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032466
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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