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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008459
Receipt No. 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

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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
Email 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
Email kxqxk574@yahoo.co.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009949

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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