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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046198
Receipt No. R000052722
Scientific Title An observational study to determine biomarkers for prognosis of lung lesions in patients with polymyositis/dermatomyositis complicated by interstitial lung disease
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/26

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Basic information
Public title An observational study to determine biomarkers for prognosis of lung lesions in patients with polymyositis/dermatomyositis complicated by interstitial lung disease
Acronym PM/DM-ILD biomarkers study
Scientific Title An observational study to determine biomarkers for prognosis of lung lesions in patients with polymyositis/dermatomyositis complicated by interstitial lung disease
Scientific Title:Acronym PM/DM-ILD biomarkers study
Region
Japan

Condition
Condition Polymyositis/dermatomyositis complicated with interstitial lung disease (PM/DM-ILD)
Classification by specialty
Medicine in general Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to explore biomarkers that define the change of lung lesions in PM/DM-ILD when immunosuppressive therapy is to be initiated.
Basic objectives2 Others
Basic objectives -Others Stratification of changes in lung lesions according to myositis-specific antibodies and search for biomarkers in bronchoalveolar lavage fluid that are associated with lung lesions.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Search for biomarkers associated with change in high-resolution CT fibrosis volume and FVC change at 52 weeks from baseline
Key secondary outcomes FVC at baseline assessment, 26 weeks, and 52 weeks
5% or more deterioration in relative change in %FVC at 52 weeks
5% or more improvement in relative change in %FVC at 52 weeks
10% or more deterioration in relative change in %FVC at 52 weeks
10% or more improvement in relative change in %FVC at 52 weeks
Lung fibrosis score at baseline assessment and at 52 weeks

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients diagnosed with PM/DM according to the criteria of the Ministry of Health, Labour and Welfare, Bohen and Peter criteria, or Sontheimer's Clinically amyopathic dermatomyositis (CADM), or patients with positive myositis-specific autoantibodies
2) Patients with ILD
3) Patients who are 20 years of age or older at the time of obtaining consent.
4) Patients planning to receive immunosuppressive therapy or receiving corticosteroids only within 8 weeks.
5) Patients with fibrotic lung disease that affects lung capacity by more than 10% on high-resolution CT.
6) Patients with FVC more than 50% of predicted and DLCO of 20-89% predicted.
7) ability and willingness to provide written informed consent and comply with the requirements of the study protocol.
Key exclusion criteria 1) Patients who have received oral corticosteroids for more than 8 weeks prior to obtaining consent.
2) Patients with malignant tumors.
3) Patients who are using or have used an anti-fibrotic therapy.
4) Patients who have undergone more than lobectomy.
5) Other patients deemed inappropriate by the investigator.
Target sample size 125

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Kawakami
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Immunology and Rheumatology
Zip code 8528501
Address 1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
TEL 095-819-7260
Email atsushik@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Toshimasa
Middle name
Last name Shimizu
Organization Nagasaki University Graduate School of Biomedical Sciences
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
Email t.shimizu@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Boehringer Ingelheim Japan, Inc.
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 Nagasaki University Hospital Clinical Research Ethics Committee
Address 1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan
Tel 095-819-7229
Email 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
2021 Year 12 Month 01 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
2021 Year 10 Month 13 Day
Date of IRB
2021 Year 11 Month 22 Day
Anticipated trial start date
2021 Year 12 Month 15 Day
Last follow-up date
2024 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study period is from the time of obtaining consent to 52 weeks.

Management information
Registered date
2021 Year 11 Month 26 Day
Last modified on
2021 Year 11 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052722

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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