UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049658 |
|---|---|
| Receipt number | R000056554 |
| Scientific Title | Study on host immune response during treatment of patients with pulmonary nontuberculous mycobacterial disease |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2024/12/02 09:09:12 |
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Basic information
Public title
Study on host immune response during treatment of patients with pulmonary nontuberculous mycobacterial disease
Acronym
PNTM study
Scientific Title
Study on host immune response during treatment of patients with pulmonary nontuberculous mycobacterial disease
Scientific Title:Acronym
PNTM study
Region
| Japan |
Condition
Condition
pulmonary nontuberculous mycobacterial disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the role of peripheral blood immune cells in pulmonary NTM patients in terms of their response to antimicrobial therapy. RNA will be collected from whole blood cells before and after treatment. The comprehensive gene expression analyses will be performed by RNA-seq.
Basic objectives2
Others
Basic objectives -Others
To identify whole blood cell-associated genes associated with response to standard therapy in patients with pulmonary NTM disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of the study is to identify the gene expression profiles in whole blood cells and serum proteins that predict the response to treatment in pulmonary NTM patients, who will be divided into a treatment (CAM+EB+RFP or EM) response group and a treatment non-response group during a 1-year observation period. Then, the validity of the biomarker will be clarified in relation to the clinical information.
Key secondary outcomes
The secondary endpoints of this study are to determine the effect of treatment (CAM/AZM+EB+RFP or EM) on pulmonary NTM disease by comparing the pre-treatment samples and post-treatment samples in terms of the gene expression in whole blood cells and serum protein levels. RNA-seq in this study will be performed at the University of Tsukuba.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, Patients who have been diagnosed with pulmonary NTM disease by the diagnostic criteria of ATS 2020 (NTM positive in sputum culture twice or culture positive in bronchial lavage fluid) before registration.
2, Patients who are not on any medication at the time of registration. In addition, at the time of enrollment in this study, the therapeutic drug must have been decided as a result of consultation and medical practice with the attending physician.
Key exclusion criteria
1. Comorbid respiratory disease: presence of any existing clinically significant known respiratory disease other than pulmonary NTM disease.
2. Malignancy: current malignancy or history of cancer that has just gone into remission less than 12 months prior to entry.
3. Liver disease: known pre-existing unstable liver disease.
4. Cardiovascular: Patients with severe or clinically significant cardiovascular disease that cannot be controlled with standard therapy.
5. Other co-morbidities: patients with known clinically significant endocrine, autoimmune, metabolic, neurologic, renal, gastrointestinal, hepatic, or hematologic disease that cannot be controlled with standard therapy. patients receiving systemic steroids for more than 4 weeks. However, patients receiving prednisolone equivalent of 10 mg/day or less of steroids will be subject to observation.
6. Pregnancy: subjects who are pregnant or lactating.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Matsuyama |
Organization
Tsukuba university hospital
Division name
Department of Respiratory Medicine
Zip code
305-8576
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3144
mmatsuyama@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Matsuyama |
Organization
Tsukuba university hospital
Division name
Department of Respiratory Medicine
Zip code
305-8576
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3144
Homepage URL
mmatsuyama@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Takeda Science Foundation
Insmed Incorporated, INVESTIGATOR-INITIATED RESEARCH grant
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
Tsukuba clinical research and development organization
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
| 2022 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
The paper is being prepared.
Number of participants that the trial has enrolled
100
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Analysis is currently underway.
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 15 | 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
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Macrolides, key drugs in pulmonary NTM disease, are not only antibiotics but also immune modulators. Therefore, it may be possible to identify whole blood cell-associated genes (immune-related genes) associated with response to standard therapy in patients with pulmonary NTM disease.
Management information
Registered date
| 2022 | Year | 12 | Month | 01 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056554
