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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038598
Receipt No. R000043988
Scientific Title MDA5 polymorphism study
Date of disclosure of the study information 2019/12/09
Last modified on 2019/11/15

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Basic information
Public title Study of polymorphism of MDA5 gene in dermatomyositis associated interstitial lung disease with anti-MDA5 antibody
Acronym MDA5 polymorphism study
Scientific Title MDA5 polymorphism study
Scientific Title:Acronym MDA5 polymorphism study
Region
Japan

Condition
Condition Dermatomyositis associated interstitial lung disease
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Detecting risk gene for development of anti-MDA5 antibody-positive dermatomyositis-associated rapid progressive interstitial lung disease
Basic objectives2 Others
Basic objectives -Others None
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Detecting risk SNP for development of anti-MDA5 antibody-positive dermatomyositis-associated interstitial lung disease
Key secondary outcomes 1. Detecting risk SNP for development of ILD in anti-MDA5 antibody-positive dermatomyositis
2, Comparison of SNP frequency between anti-MDA5 antibody-positive dermatomyositis-associated interstitial lung disease patients and disease control.
3. Study of association between disease associated SNP frequency and clinical data.
4. Study of association between disease associated SNP frequency and overall survival.

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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet criteria of dermatomyositis
Key exclusion criteria 1, Patients who were determined inappropriate for this study
2, Patients who have other diseases other than interstitial lung disease
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Tomoaki
Middle name
Last name Hoshino
Organization Kurume University School of Medicine
Division name Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine,
Zip code 8300011
Address Asahi-machi 67, Kurume, Fukuoka
TEL 0942-31-7560
Email hoshino@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Okamoto
Organization Kurume University School of Medicine
Division name Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine,
Zip code 8300011
Address Asahi-machi 67, Kurume, Fukuoka
TEL 0942-31-7560
Homepage URL
Email okamoto_masaki@med.kurume-u.ac.jp

Sponsor
Institute Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine,Kurume University School of Medicine
Institute
Department

Funding Source
Organization Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine,Kurume University School of Medicine
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 Academic Research Organization of Kurume University School of Medicine
Address Asahi-machi 67, Kurume, Fukuoka
Tel 0942-35-3311
Email sangakuml@kurume-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
2019 Year 12 Month 09 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 09 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Performing monitoring of outcome, blood data, and pulmonary function

Management information
Registered date
2019 Year 11 Month 15 Day
Last modified on
2019 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043988

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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