UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056067 |
|---|---|
| Receipt number | R000064060 |
| Scientific Title | Significance of molecular epidemiological surveillance for non-tuberculous mycobacterial pulmonary disease: a single center prospective cohort study |
| Date of disclosure of the study information | 2024/11/06 |
| Last modified on | 2024/11/06 09:46:29 |
* 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
Significance of molecular epidemiological surveillance for non-tuberculous mycobacterial pulmonary disease: a single center prospective cohort study
Acronym
Molecular Surveillance of NTM Lung Disease: Single-Center Cohort Study
Scientific Title
Significance of molecular epidemiological surveillance for non-tuberculous mycobacterial pulmonary disease: a single center prospective cohort study
Scientific Title:Acronym
Molecular Surveillance of NTM Lung Disease: Single-Center Cohort Study
Region
| Japan |
Condition
Condition
Nontuberclousis mycobacteria
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
1. To comprehensively investigate strain replacements and their impact in nontuberculous mycobacteria (NTM) over a defined period.
2. To evaluate the effectiveness of NGS-based digital VNTR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Frequency of species and strain changes over approximately 1.5 years
2. Concordance rate between digital VNTR and conventional VNTR
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 diagnosed with or suspected of NTM-PD, based on international guidelines, who provided written informed consent.
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kida |
Organization
Osaka Toneyama Medical Center
Division name
Respiratory medicine
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka, Japan
TEL
06-6853-2001
kida.hiroshi.sv@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Hashimoto |
Organization
Osaka Toneyama Medical Center
Division name
Respiratory medicine
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka, Japan
TEL
06-6853-2001
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
Osaka Toneyama Medical Center
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, Japan
Tel
06-6853-2001
k.hashimoto@imed3.med.osaka-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
| 2024 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
In preparation for publishing
Number of participants that the trial has enrolled
112
Results
Of the 112 cases analyzed, 13 (11.6%) showed changes in the species of bacteria, 15 (13.4%) showed changes in the VNTR type, but not in the species of bacteria, and 84 (75.0%) showed no changes in either the species of bacteria or the VNTR type. The results of dVNTR typing were consistent with those of conventional VNTR typing, and it was possible to easily perform typing at the strain level.
Results date posted
| 2024 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 232 patients were participated in this prospective study, of which 166 had positive sputum cultures in the enrollment period (From 1 March 2021, to 31 March 2022). Follow-up positive cultures at least more than eight months apart were obtained in 112 patients (from enrollment to December 2023). The median interval was 1.5 years (IQR 1.1-1.9). Analysis was also performed on isolates from 4 cases in which culture specimens showed different colony growth and characteristics. The median age of the cohort was 72 years (IQR 67-80), with 81 women (71.9%), and the median BMI was 19.1 (IQR 16.4-22.5). Radiological findings revealed the nodular bronchiectatic form without cavitation in 59 patients (52.2%).
Participant flow
We have established the prospective cohort of NTM. We enrolled patients who had been diagnosed with or suspected of NTM-PD, in accordance with international guideline.
Adverse events
None
Outcome measures
We performed a time-course analysis of species, subspecies, strains and drug susceptibilities using core genome multi locus sequencing typing (cgMLST) based on whole genome sequencing and variable numbers of tandem repeats (VNTR) typing, and drug susceptibility testing at approximately 1.5-year intervals. In addition, we developed a simple long-read sequencing-based digital VNTR (dVNTR) typing and evaluated its efficacy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation only
Management information
Registered date
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064060
