UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027652 |
|---|---|
| Receipt number | R000027566 |
| Scientific Title | Role of pulmonary collectins and antimicrobial peptides in patients with pulmonary nontuberculous mycobacteria disease |
| Date of disclosure of the study information | 2017/06/09 |
| Last modified on | 2023/09/27 09:00:20 |
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Basic information
Public title
Role of pulmonary collectins and antimicrobial peptides in patients with pulmonary nontuberculous mycobacteria disease
Acronym
Collectins and antimicrobial peptides in patients with pulmonary nontuberculous mycobacteria disease
Scientific Title
Role of pulmonary collectins and antimicrobial peptides in patients with pulmonary nontuberculous mycobacteria disease
Scientific Title:Acronym
Collectins and antimicrobial peptides in patients with pulmonary nontuberculous mycobacteria disease
Region
| Japan |
Condition
Condition
Pulmonary nontuberculous mycobacterial disease
Classification by specialty
| Pneumology | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between pulmonary collectins and antimicrobial peptides levels in BALF and blood, and disease severity in patients with pulmonary nontuberculous mycobacteria disease
Basic objectives2
Others
Basic objectives -Others
To evaluate the association between pulmonary collectins and antimicrobial peptides levels in BALF and blood, and prognosis in patients with pulmonary nontuberculous mycobacteria disease
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pulmonary collectins and antimicrobial peptides levels in BALF and blood, composition of microbiome, and disease severity at diagnosis, at a year and two years after diagnosis.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who match the diagnostic criteria of ATS/IDSA guidelines 2007.
Key exclusion criteria
Patients with HIV infection or disseminated MAC infection, without CRT scan data are excluded.
Patients whose observational time is less than 12 months.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
1-1, Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto
TEL
0756419161
kfujita-oka@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
1-1, Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto
TEL
0756419161
Homepage URL
kfujita-oka@umin.ac.jp
Sponsor or person
Institute
Division of Respiratory Medicine,
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1, Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto
Tel
0756419161
kfujita-oka@umin.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
国立病院機構京都医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
https://bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-022-02206-5
Publication of results
Published
Result
URL related to results and publications
https://bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-022-02206-5
Number of participants that the trial has enrolled
69
Results
The KCQ revealed that the proportion of frail NTM patients at diagnosis was higher than that of frail
BE patients (48.5% vs. 22.2%, p = 0.026). HADS scores were significantly higher in the NTM group than in the BE group
(p < 0.01). Bronchoalveolar lavage fluid (BALF) hCAP/LL-37 and SP-D levels were significantly higher (p = 0.001), but
serum hCAP/LL-37 levels were significantly lower in the NTM group than in the BE group (p = 0.023).
Results date posted
| 2023 | Year | 09 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 11 | Month | 03 | Day |
Baseline Characteristics
Nontuberculous mycobacterial lung disease patients and bronchiectasis patients
Participant flow
Prospective recruitment of patients with suspected NTM-LD for bronchoscopy.
Bronchoscopy results were assigned to patients with NTM-LD and those with bronchiectasis.
Adverse events
None
Outcome measures
The Kihon Checklist Questionnaire (KCQ) was used to assess physical and psychiatric frailties and identify
those at risk of requiring care among patients with newly diagnosed NTM-LD and BE. Additionally, the Hospital
Anxiety and Depression Scale (HADS) scores and chronic inflammatory biomarkers of the alveolar region (surfactant
protein [SP]-A, SP-D, and human cationic antibacterial protein [hCAP]/LL-37) were assessed and compared between
NTM-LD and BE patients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 01 | Day |
Other
Other related information
Nothing in particular.
Management information
Registered date
| 2017 | Year | 06 | Month | 06 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027566
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/09/14 | 研究実施計画書(肺MAC症とコレクチン).docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
