UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051997 |
|---|---|
| Receipt number | R000058679 |
| Scientific Title | Biomarkers of organ involvements and severity in idiopathic inflammatory myopathies |
| Date of disclosure of the study information | 2023/08/24 |
| Last modified on | 2025/02/23 16:38:01 |
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Basic information
Public title
Biomarkers of organ involvements and severity in idiopathic inflammatory myopathies
Acronym
Biomarkers of organ involvements and severity in idiopathic inflammatory myopathies
Scientific Title
Biomarkers of organ involvements and severity in idiopathic inflammatory myopathies
Scientific Title:Acronym
Biomarkers of severity in idiopathic inflammatory myopathies
Region
| Japan |
Condition
Condition
idiopathic inflammatory myopathies
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify clinical characteristic and biomarkers for distinguishing with organ involvements and severity,and muscle damages in patients with idiopathic inflammatory myopathies.
Basic objectives2
Others
Basic objectives -Others
To explore specific biomarkers in patients with idiopathic inflammatory myopathies.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The clinical characteristic and biomarkers for distinguishing with organ involvements and severity,and muscle damages in patients with idiopathic inflammatory myopathies.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with diagnosed idiopathic inflammatory myopathies between January 2007 and March 2023 at Nagasaki University Hospital
Key exclusion criteria
N/A
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawakami |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
TEL
095-819-7260
atsushik@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshimasa |
| Middle name | |
| Last name | Shimizu |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
TEL
095-819-7262
Homepage URL
tshimizu-ngs@umin.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Immunology and Rheumatology, Nagasaki University Hospital
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
Tel
095-819-7229
gaibushikin@ml.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
| 2023 | Year | 08 | Month | 24 | 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
195
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
| 2023 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to identify clinical characteristic and biomarkers for distinguishing with organ involvements and severity,and muscle damages in patients with idiopathic inflammatory myopathies.
Management information
Registered date
| 2023 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058679
