UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042731 |
|---|---|
| Receipt number | R000048779 |
| Scientific Title | Prognostic factors for patients with anti-melanoma differentiation-associated gene 5 (MDA-5) antibody positive idiopathic inflammatory myopathy (IIM) associated interstitial lung disease (ILD): a single centor retrospective cohort study |
| Date of disclosure of the study information | 2020/12/16 |
| Last modified on | 2020/12/11 21:41:44 |
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Basic information
Public title
Prognostic factors for patients with anti-melanoma differentiation-associated gene 5 (MDA-5) antibody positive idiopathic inflammatory myopathy (IIM) associated interstitial lung disease (ILD): a single centor retrospective cohort study
Acronym
Not applicable
Scientific Title
Prognostic factors for patients with anti-melanoma differentiation-associated gene 5 (MDA-5) antibody positive idiopathic inflammatory myopathy (IIM) associated interstitial lung disease (ILD): a single centor retrospective cohort study
Scientific Title:Acronym
Not applicable
Region
| Japan |
Condition
Condition
anti-MDA-5 antibody-positive patients with IIM associated ILD
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore the prognostic factors limited to patients with anti-MDA-5 antibody positive IIM associated ILD.
Basic objectives2
Others
Basic objectives -Others
Mortality at 3months, 6 months, 12 months, and 24 months
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Mortality at 12 months
Key secondary outcomes
Mortality at 3months, 6 months, and 24 months
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
MDA-5 antibody positive IIM associated ILD
Key exclusion criteria
Not applicable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Yanai |
Organization
Showa University
Division name
Division of Rheumatology, Department of Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
+81-3-3784-8942
ryo.yanai@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Yanai |
Organization
Showa University
Division name
Division of Rheumatology, Department of Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
+81-3-3784-8942
Homepage URL
ryo.yanai@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Division of Rheumatology, Department of Medicine
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Not applicable
Name of secondary funder(s)
Not applicable
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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
昭和大学病院（東京都）Showa University Hospital
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
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
Preinitiation
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2020 | Year | 12 | Month | 11 | Day |
Last modified on
| 2020 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048779
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| Registered date | File name |
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