UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041449 |
|---|---|
| Receipt number | R000047285 |
| Scientific Title | Longitudinal associations between cytokine profiles, disease activity indices and clinical phenotypes in patients with systemic lupus erythematosus; a prospective cohort study |
| Date of disclosure of the study information | 2020/08/18 |
| Last modified on | 2025/03/06 02:54:17 |
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Basic information
Public title
Longitudinal associations between cytokine profiles, disease activity indices and clinical phenotypes in patients with systemic lupus erythematosus; a prospective cohort study
Acronym
Longitudinal associations between cytokine profiles, disease activity indices and clinical phenotypes in patients with systemic lupus erythematosus; a prospective cohort study
Scientific Title
Longitudinal associations between cytokine profiles, disease activity indices and clinical phenotypes in patients with systemic lupus erythematosus; a prospective cohort study
Scientific Title:Acronym
Longitudinal associations between cytokine profiles, disease activity indices and clinical phenotypes in patients with systemic lupus erythematosus; a prospective cohort 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 longitudinal associations between cytokine/chemokine profiles, clinical phenotypes, disease activity indices, relapse and other clinical variables in patients with systemic erythematosus.
Basic objectives2
Others
Basic objectives -Others
Pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inflammatory cytokines/disease activity indices
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 are referred to the Department of Allergy and Clinical Immunology, Chiba University Hospital or related facilities and fulfill 1997 ACR SLE Criteria.
2. Patients who agree to participate in this study with written informed consent.
3. Age of 20 or older at the time of consent.
Key exclusion criteria
1. Patients with concomitant autoimmune diseases, except Sjogren's syndrome.
2. Patients who do not agree to participate in this study.
3. Patients who can not provide blood and/or urine samples.
4. Patients with conditions which are considered inappropriate for this study.
Target sample size
200
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
Ministray of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 08 | Month | 18 | 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
170
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Preparing to publish results
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
| 2020 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
inflammatory cytokines/disease activity indices
Management information
Registered date
| 2020 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047285
