UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018663 |
|---|---|
| Receipt number | R000021611 |
| Scientific Title | Multicenter cohort study identifying prognostic factors in patients with polymyositis/dermatomyositis and interstitial lung disease |
| Date of disclosure of the study information | 2015/08/24 |
| Last modified on | 2022/08/18 15:05:58 |
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Basic information
Public title
Multicenter cohort study identifying prognostic factors in patients with polymyositis/dermatomyositis and interstitial lung disease
Acronym
PM/DM-ILD cohort study
Scientific Title
Multicenter cohort study identifying prognostic factors in patients with polymyositis/dermatomyositis and interstitial lung disease
Scientific Title:Acronym
PM/DM-ILD cohort study
Region
| Japan |
Condition
Condition
polymyositis/dermatomyositis with interstitial lung disease
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify prognostic factors, including autoantibodies, imaging, and therapeutic regimens
Basic objectives2
Others
Basic objectives -Others
To evaluate regional and seasonal differences among disease subsets based on autoantibody profiles
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Survival at 3, 6, and 12 months
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age equal or greater than 16 years
2. Clinical diagnosis of polymyositis or dermatomyositis, including clinically amyopathic dermatomyositis
3. Presence of interstitial lung disease by chest X ray or high-resolution CT scan
4. myositis-specific autoantibody identified or availability of serum samples used for identification of myositis-specific autoantibodies
Key exclusion criteria
Observation period < 6 months unless death
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Kuwana |
Organization
Nippon Medical School
Division name
Department of Allergy and Rheumatology
Zip code
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
kuwanam@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masataka Kuwana |
Organization
Nippon Medical School
Division name
Department of Allergy and Rheumatology
Zip code
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
kuwanam@nms.ac.jp
Sponsor or person
Institute
Anti-CADM-140 Antibody Study Group
Institute
Department
Personal name
Funding Source
Organization
Astellas
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本医科大学（東京都）、東海大学（神奈川県）、長崎大学（長崎県）、東京女子医科大学（東京都）、自治医科大学付属さいたま医療センター（埼玉県）、防衛医科大学校（埼玉県）、横浜市立大学（神奈川県）、久留米大学（福岡県）、高知大学（高知県）、埼玉医科大学総合医療センター（埼玉県）、山口大学（山口県）、鹿児島大学（鹿児島県）、千葉大学（千葉県）、東京慈恵会医科大学（東京都）、東京慈恵会医科大学葛飾医療センター（東京都）、東邦大学医療センター大橋病院（東京都）、東邦大学医療センター大森病院（東京都）、東邦大学医療センター佐倉病院（千葉県）、藤田保健衛生大学（愛知県）、福島県立医科大学（福島県）、慶應義塾大学（東京都）、順天堂大学浦安病院（千葉県）、新潟大学（新潟県）、大分大学（大分県）、川崎市立川崎病院（神奈川県）、杏林大学（東京都）、複十字病院（東京都）、平塚共済病院（神奈川県）、山形済生病院（山形県）、東京逓信病院（東京都）、名古屋大学（愛知県）、名古屋市立大学（愛知県）、東京都立多摩総合医療センター（東京都）、北里大学（神奈川県）、岡山医療センター（岡山県）、神奈川県立循環器呼吸器病センター（神奈川県）、大阪南医療センター（大阪府）、済生会熊本病院（熊本県）、済生会新潟第2病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2015 | 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
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
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective/prospective observational study for evaluating correlations between survivals and clinical parameters, including autoantibodies, imaging, and therapeutic regimens, using random sampling
Management information
Registered date
| 2015 | Year | 08 | Month | 13 | Day |
Last modified on
| 2022 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021611
| Research Plan | |
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| 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 |
