UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032303 |
|---|---|
| Receipt number | 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 | 2023/10/23 07:17:18 |
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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 | Tetsuo |
| Middle name | |
| Last name | Kubota |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4773
tetsuo.kubota.mtec@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Kubota |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4773
Homepage URL
tetsuo.kubota.mtec@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
syomu1.acm@tmd.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
| 2018 | Year | 10 | Month | 01 | 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
40
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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036842
