UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063302 |
|---|---|
| Receipt number | R000072456 |
| Scientific Title | The Japanese Bronchiectasis & NTM Registry for Advanced Innovation and Networking |
| Date of disclosure of the study information | 2026/10/19 |
| Last modified on | 2026/10/15 23:23:30 |
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Basic information
Public title
The Japanese Bronchiectasis & NTM Registry for Advanced Innovation and Networking
Acronym
Bronchiectasis and Nontuberculous Mycobacterial Pulmonary Disease Registry Study
Scientific Title
The Japanese Bronchiectasis & NTM Registry for Advanced Innovation and Networking
Scientific Title:Acronym
Bronchiectasis and Nontuberculous Mycobacterial Pulmonary Disease Registry Study
Region
| Japan |
Condition
Condition
Bronchiectasis and/or non-tuberculosis mycobacterial pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to establish a nationwide, multicenter, observational registry (J-BRAIN) for bronchiectasis and nontuberculous mycobacterial pulmonary disease (NTM-PD).
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to establish a nationwide, multicenter, observational registry (J-BRAIN) to prospectively collect standardized clinical, imaging, and microbiological data, as well as biological samples, from patients with symptomatic bronchiectasis or a history of exacerbations and those with related conditions, including nontuberculous mycobacterial pulmonary disease (NTM-PD). Through this registry, we aim to establish a comprehensive data platform to facilitate disease stratification, prognostic prediction, and the development of personalized medicine.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical outcomes, including disease exacerbations and mortality, in patients with bronchiectasis and nontuberculous mycobacterial pulmonary disease (NTM-PD). Outcome measures include the annual exacerbation rate, time to first exacerbation, occurrence of exacerbations requiring hospitalization, all-cause mortality, and respiratory-related mortality.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Bronchiectasis
Patients diagnosed with bronchiectasis according to international diagnostic criteria, based on radiological findings and clinical symptoms (chronic cough, sputum production, or a history of exacerbations). Patients with asymptomatic or minimally symptomatic bronchiectasis identified solely by radiological findings will be excluded.
2. Nontuberculous mycobacterial pulmonary disease (NTM-PD)
Patients who meet the ATS/ERS/ESCMID/IDSA diagnostic criteria for NTM-PD, including compatible clinical symptoms, radiological findings (bronchiectasis), and microbiological criteria. Patients with asymptomatic or minimally symptomatic NTM-PD presenting with a mild nodular bronchiectatic (NB) phenotype will be excluded.
Key exclusion criteria
Patients who do not provide informed consent to participate in this study. Patients younger than 18 years of age.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Kozo |
| Middle name | |
| Last name | Morimoto |
Organization
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Division name
Respiratory Disease Center
Zip code
2048522
Address
3-1-24 Matsuyama, Kiyose, Tokyo, Japan
TEL
0424914111
morimotok@fukujuji.org
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Ito |
Organization
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Division name
Respiratory Disease Center
Zip code
204-852
Address
3-1-24 Matsuyama, Kiyose, Tokyo, Japan
TEL
0424914111
Homepage URL
https://j-brain.org/
itom@fukujuji.org
Sponsor or person
Institute
J-BRAIN
Institute
Department
Personal name
Funding Source
Organization
J-BRAIN
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
Ethics Committee, Fukujuji Hospital, Japan Anti-Tuberculosis Association
Address
3-1-24 Matsuyama, Kiyose-shi, Tokyo, Japan
Tel
0424914111
arai_tomonori@jata.or.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
| 2026 | Year | 10 | Month | 19 | 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
| 2026 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2036 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Secondary Outcomes:
Secondary outcomes include the clinical phenotypes and patient characteristics of bronchiectasis and nontuberculous mycobacterial pulmonary disease (NTM-PD); associations between treatment regimens and clinical course or prognosis; associations of radiological findings and pulmonary function parameters with clinical outcomes; and associations of pathogen genotypes and antimicrobial susceptibility profiles with clinical manifestations.
Clinical information, imaging data, microbiological test results, and microbial isolate analysis results recorded in the patient database will be integrated to evaluate their associations with clinical phenotypes and prognosis using statistical methods, including between-group comparisons and regression analyses. Imaging data, including chest radiographs and computed tomography (CT) scans, will be evaluated qualitatively or quantitatively using dedicated image analysis software or programs.
Exploratory Outcomes:
Exploratory outcomes include associations between genomic and omics data and clinical phenotypes; associations of host genetic variants and epigenomic alterations with disease onset and progression; identification of molecular biomarkers derived from blood and respiratory samples; and associations of pathogen genomic characteristics with clinical manifestations and treatment responses.
Genomic and omics analyses, including whole-genome sequencing, RNA sequencing, single-nucleotide polymorphism (SNP) array analysis, DNA methylation analysis, metabolomics, and proteomics, will be performed using DNA, RNA, serum, plasma, and peripheral blood mononuclear cells (PBMCs) obtained from blood and respiratory samples collected at participating institutions.
Management information
Registered date
| 2026 | Year | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072456
