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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025538
Receipt No. R000029394
Scientific Title Clinical study to analyze the pathogenesis of systemic lupus erythematosus by multi-faceted approach
Date of disclosure of the study information 2017/01/06
Last modified on 2017/01/05

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Basic information
Public title Clinical study to analyze the pathogenesis of systemic lupus erythematosus by multi-faceted approach
Acronym Clinical study to analyze the pathogenesis of systemic lupus erythematosus
Scientific Title Clinical study to analyze the pathogenesis of systemic lupus erythematosus by multi-faceted approach
Scientific Title:Acronym Clinical study to analyze the pathogenesis of systemic lupus erythematosus
Region
Japan

Condition
Condition Systemic lupus erythematosus
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Systemic lupus erythematosus (SLE), an autoimmune disorder characterized by the production of pathogenic autoantibodies and inflammatory mediators,involves multiple organ systems.Neuropsychiatric systemic lupus erythematosus (NPSLE) manifests as a range of neurological and psychiatric features. Here, we are planning the study to evaluate the clinical impact of SLE using blood, fluid (eg; pleural effusion, ascites, cerebrospinal fluid, urine ),biopsy samples and determine the factor that related to the pathogenesis by multi-faceted approach. Regardless of advances in the understanding of the immune mechanisms, SLE remains a diagnostic and therapeutic challenge. We expect that development of diagnostic approach may help to improve the quality of diagnosis and predict its prognosis factor.
Basic objectives2 Others
Basic objectives -Others Investigation of newly biomarker and diagnostic aprroach for SLE
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) patient background
a)patient ID
b)patient height, weight
c)therapeutic regimen
2)Clinical findings and data
investigating the following data every year
a) blood pressure
b) urine: proteinuria, Cr, RBC count, urine volume
c)renal function:Ccr, BUN, Cr, eGFR
d)Hematological study: RBC, Hb, Ht, WBC, PLT
e)biochemistry,immunological test:TP, Alb, T-chol, TG, LDL-C, IgA, IgM, IgG, C3, C4, AST, UA, anti-double strand(ds)DNA antibodies, CH50, anti-C1q immune complex, anti-nuclear antibodies
f)kidney histological findings
g)radio graphic image:CT, MRI, ultrasound, PWV(Pulse Wave Velocity),electroencephalogram, SPECT
h)cerebrospinal fluid:cytokine, cell number, pressure, protein, glucose
i)other:pleural effusion, ascites, biopsy sample
Key secondary outcomes investigating every year

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients of SLE, connective tissue disease including Sjogren syndrome, systemic sclerosis, vasculitis syndrome and rapid progressive glomerulonephritis are enrolled to this study.
Key exclusion criteria The patient who dis not agree to this study was excluded.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiro Ichinose
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences
Zip code
Address 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
TEL 095-819-7262
Email kichinos@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiro Ichinose
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences
Zip code
Address 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
TEL 095-819-7262
Homepage URL
Email kichinos@nagasaki-u.ac.jp

Sponsor
Institute Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2012 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design:cohort study
Patient enrollment:We studied the patients who were visited to Nagasaki University Hospital during the 10-year period from 2006 through 2016 and fulfilled at least four of the 11 revised criteria of the American College of Rheumatology (ACR) for the classification of SLE.

Management information
Registered date
2017 Year 01 Month 05 Day
Last modified on
2017 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029394

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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