UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046198 |
|---|---|
| Receipt number | 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 | 2024/11/28 11:16:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
t.shimizu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Enrolling by invitation
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
| 2026 | Year | 06 | Month | 30 | 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
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052722
