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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032303
Receipt No. R000036842
Scientific Title A study to detect pathogenic activity of autoantibodies in connective tissue diseases.
Date of disclosure of the study information 2018/10/01
Last modified on 2018/04/19

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Basic information
Public title A study to detect pathogenic activity of autoantibodies in connective tissue diseases.
Acronym pathogenic activity of autoantibodies
Scientific Title A study to detect pathogenic activity of autoantibodies in connective tissue diseases.
Scientific Title:Acronym pathogenic activity of autoantibodies
Region
Japan

Condition
Condition systemic lupus erythematosus, anti phospholipid syndrome, systemic sclerosis, mixed connective tissue disease, vasculitis syndrome
Classification by specialty
Clinical immunology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To make clear the pathogenic role of autoantibodies.
Basic objectives2 Others
Basic objectives -Others To observe the effect of autoantibodies on the function of cells.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes not applicable, because this is an in vitro study.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 We obtain about 10 ml of peripheral blood sample from the patients. If necessary, repeat the sampling once again after several months interval.
Interventions/Control_2 We obtain about 10 ml of peripheral blood sample from thehealthy control. If necessary, we may repeat the sampling after 2 weeks or longer interval.
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 patients with above described diseases, and healthy controls
Key exclusion criteria people who decline to participate in this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Kubota
Organization Tokyo Medical and Dental University
Division name Graduate School of Medical and Dental Sciences
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5369
Email tetsuo.kubota.mtec@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuo Kubota
Organization Tokyo Medical and Dental University
Division name Graduate School of Medical and Dental Sciences
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5369
Homepage URL
Email tetsuo.kubota.mtec@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization JSPS
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Soka City Hospital
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
2018 Year 10 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
2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 05 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

Management information
Registered date
2018 Year 04 Month 18 Day
Last modified on
2018 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036842

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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