UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
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	Shumpei Yokota
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Pediatrics
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	Shumpei Yokota
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Pediatrics
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009949