UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061160 |
|---|---|
| Receipt number | R000069989 |
| Scientific Title | A multicenter prospective observational study evaluating the utility of gastric aspirate culture and post-bronchoscopy sputum for the diagnosis of pulmonary nontuberculous mycobacterial disease |
| Date of disclosure of the study information | 2026/04/15 |
| Last modified on | 2026/04/08 08:30:47 |
* 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
Bronchoscopy plus post-bronchoscopy sputum and gastric fluid for improved NTM diagnosis
Acronym
BOOST-NTM Study
Scientific Title
A multicenter prospective observational study evaluating the utility of gastric aspirate culture and post-bronchoscopy sputum for the diagnosis of pulmonary nontuberculous mycobacterial disease
Scientific Title:Acronym
BOOST-NTM Study
Region
| Japan |
Condition
Condition
nontuberculous mycobacterial pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate, in a multicenter prospective observational setting, the incremental diagnostic yield obtained by adding gastric aspirate culture and post-bronchoscopy sputum (PBS) to bronchoscopy in patients with suspected pulmonary nontuberculous mycobacterial disease who undergo bronchoscopic examination.
Furthermore, this study aims to assess the usefulness of a diagnostic approach combining these specimens and to clarify the optimal bronchoscopy-based diagnostic protocol for NTM-PD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the incremental diagnostic yield of adding gastric aspirate culture and post-bronchoscopy sputum (PBS) to bronchoscopy for the diagnosis of pulmonary nontuberculous mycobacterial disease.
Key secondary outcomes
1.Microbiological test results for each specimen (bronchoscopic specimens, gastric aspirate, and post-bronchoscopy sputum [PBS])
2.Time to culture positivity (TTP) for each specimen
3.Proportion and details of additional diagnostic cases newly diagnosed by the addition of PBS and/or gastric aspirate culture
4.Clinical characteristics of additional diagnostic cases
5.Final diagnostic classification (Definite NTM, Probable NTM, Indeterminate, and Not NTM)
6.Frequency and details of adverse events related to bronchoscopy and collection of PBS and gastric aspirate
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 suspected of having pulmonary nontuberculous mycobacterial disease (NTM-PD) based on clinical findings, including imaging findings such as nodular opacities, branching opacities, diffuse homogeneous opacities, cavitary opacities, or bronchial/bronchiolar dilatation.
2. Patients who are scheduled to undergo bronchoscopy as part of routine clinical care for the diagnosis of NTM-PD, with planned collection of post-bronchoscopy sputum (PBS) and gastric aspirate for culture.
3. Patients aged 20 years or older at the time of enrollment.
4. Patients who are unable to submit sputum for culture before bronchoscopy, or who have not had the same mycobacterial species identified as positive on two or more occasions.
5. Patients from whom written informed consent to participate in this study has been obtained.
Key exclusion criteria
1. Patients who already meet the diagnostic criteria for pulmonary nontuberculous mycobacterial disease (NTM-PD) before bronchoscopy, or who have a history of treatment for NTM-PD.
2. Patients in whom any of the following specimens were not obtained: bronchoscopic specimens, gastric aspirate for culture, or post-bronchoscopy sputum (PBS).
3. Patients in whom diseases other than NTM-PD, such as pulmonary tuberculosis or lung cancer, are strongly suspected based on clinical findings including imaging findings.
4. Patients who are otherwise considered inappropriate for participation in this study by the principal investigator or the attending physician.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Yamamoto |
Organization
University Hospital Kyoto Prefectural University of Medicine
Division name
Department of Respiratory Medicine
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5111
yama@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Imabayashi |
Organization
Japanese Red Cross Kyoto Daiichi Hospital
Division name
Department of Respiratory Medicine
Zip code
605-0981
Address
15-749 Honmachi, Higashiyama-ku, Kyoto 605-0981, Japan
TEL
075-561-1121
Homepage URL
imabayas@koto.kpu-m.ac.jp
Sponsor or person
Institute
Japanese Red Cross Kyoto Daiichi Hospital
Institute
Department
Personal name
KOHEI YAMAMOTO
Funding Source
Organization
None
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 of Kyoto First Red Cross Hospital
Address
15-749 Honmachi, Higashiyama-ku, Kyoto 605-0981, Japan
Tel
075-561-1121
soumuka@kyoto1.jrc.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
京都第一赤十字病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter prospective observational study of patients with suspected pulmonary nontuberculous mycobacterial disease undergoing bronchoscopy. No study-specific allocation, intervention, randomization, or blinding will be performed. Microbiological results of bronchoscopic specimens, gastric aspirate, and post-bronchoscopy sputum (PBS) obtained in routine clinical practice will be collected to evaluate the incremental diagnostic yield.This study will be conducted as a multicenter prospective observational study. Participating institutions will be added sequentially after ethics approval has been obtained at each institution.
Management information
Registered date
| 2026 | Year | 04 | Month | 04 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069989
