UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041841 |
|---|---|
| Receipt number | R000047465 |
| Scientific Title | Analysis of cytokine profiles in patients with systemic lupus erythematosus; a cross-sectional study |
| Date of disclosure of the study information | 2020/09/23 |
| Last modified on | 2023/09/20 23:22:33 |
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Basic information
Public title
Analysis of cytokine profiles in patients with systemic lupus erythematosus; a cross-sectional study
Acronym
Analysis of cytokine profiles in patients with systemic lupus erythematosus; a cross-sectional study
Scientific Title
Analysis of cytokine profiles in patients with systemic lupus erythematosus; a cross-sectional study
Scientific Title:Acronym
Analysis of cytokine profiles in patients with systemic lupus erythematosus; a cross-sectional study
Region
| Japan |
Condition
Condition
Systemic lupus erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the associations between cytokine/chemokine profiles, clinical phenotypes, disease activity indices and other clinical vaaiables in patients with systemic erythematosus.
Basic objectives2
Others
Basic objectives -Others
Pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cytokine profiles/Disease activity index
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who were referred to Department of Allergy and Clinical Immunology, Chiba University Hospital and fulfill 1997 ACR SLE Criteria. Among those patients, residual serum samples from the daily practice will be analyzed for this study.
2. 20 years or older when serum was taken.
Key exclusion criteria
1. Patients who have offered to opt out from this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Iwamoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Allergy and Clinical Immunology
Zip code
260-8670
Address
1-8-1 Inohoana, Chuo-ku, Chiba, Chiba
TEL
043-226-2198
taro.iwamoto@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kazusa |
| Middle name | |
| Last name | Miyachi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Allergy and Clinical Immunology
Zip code
260-8670
Address
1-8-1 Inohoana, Chuo-ku, Chiba, Chiba
TEL
043-226-2198
Homepage URL
kazusa.miyachi@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Chiba University Graduate School of Medicine, Ethics Committee
Address
1-8-1 Inohoana, Chuo-ku, Chiba, Chiba
Tel
043-226-2462
inohana-rinri@chiba-u.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
| 2020 | Year | 09 | Month | 23 | Day |
Related information
URL releasing protocol
In preparation
Publication of results
Unpublished
Result
URL related to results and publications
In preparation
Number of participants that the trial has enrolled
40
Results
In preparation
Results date posted
| 2022 | Year | 10 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In preparation
Participant flow
In preparation
Adverse events
In preparation
Outcome measures
In preparation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
inflammatory cytokines/disease activity indices
Management information
Registered date
| 2020 | Year | 09 | Month | 18 | Day |
Last modified on
| 2023 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047465
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
