UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025538 |
|---|---|
| Receipt number | 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 | 2024/01/11 09:31:32 |
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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 | Kunihiro |
| Middle name | |
| Last name | Ichinose |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
TEL
095-819-7262
kichinos@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Ichinose |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
TEL
095-819-7262
Homepage URL
kichinos@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Institute
Department
Personal name
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
Clinical research center, Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
Tel
095-819-7726
shuntarosato@nagasaki-u.ac.jp
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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029394
