UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037246 |
|---|---|
| Receipt number | R000042472 |
| Scientific Title | Analysis of mechanisms for hyper lymphocytic activation in sysytemic lupus erhythematosus |
| Date of disclosure of the study information | 2019/07/04 |
| Last modified on | 2019/07/03 10:48:47 |
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Basic information
Public title
Analysis of mechanisms for hyper lymphocytic activation in sysytemic lupus erhythematosus
Acronym
Analysis of mechanisms for hyper lymphocytic activation in sysytemic lupus erhythematosus
Scientific Title
Analysis of mechanisms for hyper lymphocytic activation in sysytemic lupus erhythematosus
Scientific Title:Acronym
Analysis of mechanisms for hyper lymphocytic activation in sysytemic lupus erhythematosus
Region
| Japan |
Condition
Condition
systemic lupus erhythema tosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate mechanisms of hyper lymphocytic activation in sysytemic lupus erhythematosus
Basic objectives2
Others
Basic objectives -Others
To elucidate mechanisms of hyper lymphocytic activation in sysytemic lupus erhythematosus
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of molecules related with hyper lymphocytic activation in sysytemic lupus erhythematosus.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Taking blood from the subjectives annually
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Systemic lupus erhythematosus
Normal healthy controls
Disease control
(Scleroderma, rheumatoid arthritis, and primary Sjogren's syndrome)
Key exclusion criteria
Person not agreed with enrollment to this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Nozawa |
Organization
Juntendo University
Division name
Department of Rheumatology
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo word, Tokyo
TEL
03-3813-3111
k-nozawa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Nozawa |
Organization
Juntendo University
Division name
Department of Rheumatology
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo word, Tokyo
TEL
03-3813-3111
Homepage URL
k-nozawa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-1-1, Hongo, Bunkyo word, Tokyo
Tel
03-3813-3111
k-nozawa@juntendo.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
順天堂大学附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 04 | 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
| 2019 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2019 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042472
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
