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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028358
Receipt No. 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

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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
Email 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
Email tishii@med.tohoku.ac.jp

Sponsor
Institute tohoku university hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032466

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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