UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008459 |
|---|---|
| Receipt number | R000009949 |
| Scientific Title | Association of HLA-DR gene polymorphism and systemic lupus erythematosus (SLE) associated genes (IRF5, BLK, STAT4, TNFAIP3, TNIP1, ETS1 and SPP1 polymorphisms) with childhood-onset SLE. |
| Date of disclosure of the study information | 2012/07/20 |
| Last modified on | 2017/01/21 17:43:39 |
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Basic information
Public title
Association of HLA-DR gene polymorphism and systemic lupus erythematosus (SLE) associated genes (IRF5, BLK, STAT4, TNFAIP3, TNIP1, ETS1 and SPP1 polymorphisms) with childhood-onset SLE.
Acronym
Association of HLA-DR gene polymorphism and systemic lupus erythematosus (SLE) associated genes (IRF5, BLK, STAT4, TNFAIP3, TNIP1, ETS1 and SPP1 polymorphisms) with childhood-onset SLE.
Scientific Title
Association of HLA-DR gene polymorphism and systemic lupus erythematosus (SLE) associated genes (IRF5, BLK, STAT4, TNFAIP3, TNIP1, ETS1 and SPP1 polymorphisms) with childhood-onset SLE.
Scientific Title:Acronym
Association of HLA-DR gene polymorphism and systemic lupus erythematosus (SLE) associated genes (IRF5, BLK, STAT4, TNFAIP3, TNIP1, ETS1 and SPP1 polymorphisms) with childhood-onset SLE.
Region
| Japan |
Condition
Condition
systemic lupus erythematosus
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate association of HLA-DR gene polymorphism and systemic lupus erythematosus (SLE) associated genes (IRF5, BLK, STAT4, TNFAIP3, TNIP1, ETS1 and SPP1 polymorphisms) with childhood-onset SLE.
Basic objectives2
Others
Basic objectives -Others
pathogenesis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of SLE
Key secondary outcomes
Subgroup analysis based on (1)clinical characteristics, (2)response to therapy, (3)the level of anti-dsDNA peptide antibodies, antinuclear antibody or complement, (4)family history of rheumatic disease and autoimmune disease, (5)complications such as renal failure.
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with childhood-onset SLE treated in our hospital and with obtained prior written informed consent from patients and/or their parents.
Key exclusion criteria
The patient judged as improper case for enrollment in this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shumpei Yokota |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2671
kxqxk574@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shumpei Yokota |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2671
Homepage URL
kxqxk574@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
横浜市立大学附属病院（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
Retrospective cohort study
Management information
Registered date
| 2012 | Year | 07 | Month | 17 | Day |
Last modified on
| 2017 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009949
| 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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