UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058129 |
|---|---|
| Receipt number | R000066443 |
| Scientific Title | Comparison of culture and culture-free methods for comprehensive identification of mycobacteria: a single center prospective study |
| Date of disclosure of the study information | 2025/06/10 |
| Last modified on | 2025/06/09 16:54:55 |
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Basic information
Public title
Comparison of culture and culture-free methods for comprehensive identification of mycobacteria: a single center prospective study
Acronym
Effectiveness of Culture-Free Methods for Detecting Mycobacteria
Scientific Title
Comparison of culture and culture-free methods for comprehensive identification of mycobacteria: a single center prospective study
Scientific Title:Acronym
Effectiveness of Culture-Free Methods for Detecting Mycobacteria
Region
| Japan |
Condition
Condition
Non-tuberculous mycobacteria pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the diagnostic performance of a novel culture-free method for subspecies-level identification of mycobacteria directly from sputum.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of culture-free methods for subspecies-Level identification of mycobacteria compared to culture methods
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
Patients were eligible if they had suspected or confirmed nontuberculous mycobacterial (NTM) pulmonary disease, or if they had other non-NTM respiratory diseases and provided sputum samples for diagnostic evaluation at Osaka Toneyama Medical Center.
Key exclusion criteria
None
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Hashimoto |
Organization
Osaka Toneyama Medical Center
Division name
Department of Respiratory Medicine
Zip code
560-8552
Address
Osaka Toneyama Medical Center, 5-1-1 Toneyama, Toyonaka, Osaka 560-8552, Japan
TEL
06-6853-2001
k.hashimoto@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Hashimoto |
Organization
Osaka Toneyama Medical Center
Division name
Department of Respiratory Medicine
Zip code
560-8552
Address
Osaka Toneyama Medical Center, 5-1-1 Toneyama, Toyonaka, Osaka 560-8552, Japan
TEL
06-6879-3831
Homepage URL
k.hashimoto@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Toneyama Medical Center
Institute
Department
Personal name
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
Osaka Toneyama Medical Center
Address
5-1-1 Toneyama, Toyonaka, Osaka 560-8552, Japan
Tel
06-6853-2001
410-chiken@mail.hosp.go.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
| 2025 | Year | 06 | Month | 10 | 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
125
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Objectives:
The genus Mycobacterium, including M. tuberculosis and over 200 NTM species, shows significant variability in clinical outcomes and drug susceptibility at species and subspecies levels. While culture-based identification is the gold standard, the slow growth of mycobacteria delays diagnosis and treatment. This study evaluated a novel culture-free method for subspecies-level identification of mycobacteria directly from sputum.
Methods:
This single-center prospective cohort study at Osaka Toneyama Medical Center analyzed 125 sputum samples from 115 patients with suspected or confirmed NTM pulmonary disease and 10 with non-NTM respiratory diseases. Samples were decontaminated using NALC-NaOH or succinic acid. Two workflows were compared: (1) the reference culture method involving mycobacterial culture and whole genome sequencing, and (2) direct target-capture sequencing as a culture-free method. Subspecies were identified using core genome MLST, covering over 380 mycobacterial species.
Results:
Among 115 NTM cases, 57 samples were smear-positive and 93 culture-positive. Identified subspecies included M. avium subsp. hominissuis (48), M. intracellulare subsp. intracellulare (22), subsp. chimaera (5), M. abscessus subsp. abscessus (7), subsp. massiliense (5), M. tuberculosis (1), and 5 others. The culture-free method identified subspecies in 75.4% of smear-positive samples (43/57) and 13.9% of smear-negative ones (5/36). NALC-NaOH pretreatment had higher accuracy (19/21, 90.5%) than succinic acid (24/36, 66.7%).
Conclusions:
The culture-free method showed high specificity and accuracy, especially in smear-positive, alkaline-treated sputum. It offers a promising alternative for rapid diagnosis and timely treatment, avoiding the delays of culture-based methods.
Management information
Registered date
| 2025 | Year | 06 | Month | 09 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066443
