UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038598 |
|---|---|
| Receipt number | R000043988 |
| Scientific Title | MDA5 polymorphism study |
| Date of disclosure of the study information | 2019/12/09 |
| Last modified on | 2025/05/20 22:34:50 |
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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
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
okamoto_masaki@med.kurume-u.ac.jp
Sponsor or person
Institute
Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine,Kurume University School of Medicine
Institute
Department
Personal name
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
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences
Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine
Department of Respirology, NHO Kyushu Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center of Kurume University School of Medicine
Address
Asahi-machi 67, Kurume, Fukuoka
Tel
0942-65-3749
i_rinri@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
206
Results
Analysis had been finished. On writing article.
Results date posted
| 2023 | Year | 11 | Month | 18 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to delays in writing the thesis
Date of the first journal publication of results
Baseline Characteristics
Dermatomyositis 206 cases
Participant flow
Cases who visited to collaborative faculties.
Adverse events
None
Outcome measures
Primary endpoint: Detection of risk MDA5 gene variant for anti-MDA5 antibody-positive DM-ILD
Secondary endpoint:
1. Detection of risk MDA5 gene variant for ILD in anti-MDA5 antibody-positive DM
2. Comparison of MDA5 gene variant frequency between anti-MDA5 antibody-positive DM-LD and disease controls
3. Association analysis between pathology-related candidate MDA5 gene variant frequency and clinical data in anti-MDA5 antibody-positive DM-ILD
Plan to share IPD
Anonymized and stored at the representative facility
IPD sharing Plan description
In this study, to protect personal information, the patient ID, name, address, etc. of the research subjects will be replaced with a research ID, and the samples and information will be anonymized at the start of the study so that it is not immediately clear which research subject they belong to. A correspondence table will be created to identify the research subjects if necessary. The correspondence table will be stored securely under the personal information manager. The storage period for the correspondence table will be the same as that for information related to the research.
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this multicenter prospective study, 206 participants with dermamyositis were registrated.
Recrutment of participants were closed and data is now analyzing.
Management information
Registered date
| 2019 | Year | 11 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043988
