UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034052 |
|---|---|
| Receipt number | R000038815 |
| Scientific Title | Clinical study to analyze the modification of autoinflammatory disease-related gene abnormalities on the pathology of systemic lupus erythematosus |
| Date of disclosure of the study information | 2018/09/10 |
| Last modified on | 2018/09/06 13:01:34 |
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Basic information
Public title
Clinical study to analyze the modification of autoinflammatory disease-related gene abnormalities on the pathology of systemic lupus erythematosus
Acronym
The modification of autoinflammatory disease-related gene abnormalities on the pathology of systemic lupus erythematosus
Scientific Title
Clinical study to analyze the modification of autoinflammatory disease-related gene abnormalities on the pathology of systemic lupus erythematosus
Scientific Title:Acronym
The modification of autoinflammatory disease-related gene abnormalities on the pathology of systemic lupus erythematosus
Region
| Japan |
Condition
Condition
Systemic lupus erythematosus (SLE)
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Elucidation of pathology
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elucidation of differences between clinical findings of SLE with and without autoinflammatory disease-related gene abnormality
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
SLE patients who satisfy the classification criteria.
Key exclusion criteria
Patients judged inappropriate as subjects of research.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Koga |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Immunology and Rheumatology
Zip code
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
TEL
095-819-7200
tkoga@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yushiro Endo |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Immunology and Rheumatology
Zip code
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
TEL
095-819-7200
Homepage URL
yushiro19861105@hotmail.co.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
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
| 2018 | Year | 09 | Month | 10 | 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
| 2018 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 09 | Month | 06 | Day |
Last modified on
| 2018 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038815
| Research Plan | |
|---|---|
| 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 |
