UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052654 |
|---|---|
| Receipt number | R000059727 |
| Scientific Title | Pathogenesis of development of non-tuberculous mycobacterial lung disease with a focus on ciliary movement in the airway epithelium |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/02/24 00:35:08 |
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Basic information
Public title
Pathogenesis of development of non-tuberculous mycobacterial lung disease with a focus on ciliary movement in the airway epithelium
Acronym
Ciliary movement and development of non-tuberculous mycobacterial lung disease
Scientific Title
Pathogenesis of development of non-tuberculous mycobacterial lung disease with a focus on ciliary movement in the airway epithelium
Scientific Title:Acronym
Ciliary movement and development of non-tuberculous mycobacterial lung disease
Region
| Japan |
Condition
Condition
non-tuberculous mycobacterial lung disease, bronchiectasis
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Airway epithelial cells are collected directly from patients with NTM-LD by bronchoscopy and analysed for lineage movement, etc., to elucidate the infection mechanism and patient background from the perspective of cell function on the host side. One problem with the analysis of airway epithelial cell function in clinical samples was the question of whether abnormalities in cell function (fibrillary motility) were the cause of NTM infection or the result of NTM infection, in a so-called 'chicken and egg' relationship.
Therefore, by reproducing airway epithelial cells from patients with NTM-LD in vitro using iPS cell technology from peripheral blood, functional evaluation was carried out in a system excluding acquired factors affecting airway epithelial cell function, such as infection on the host side or exposure to other smokes, and by comparing them with airway epithelial cells directly from the patient, Aiming to elucidate more essential mechanisms.
Basic objectives2
Others
Basic objectives -Others
Electron microscopic analysis of lineage structure.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To determine the differences between the fibrillary motility of airway epithelium directly collected bronchoscopically from patients with NTM-LD and that of airway epithelium established from peripheral blood mononuclear cell-derived iPS cells collected from the same patients.
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 with suspected NTM-LD and scheduled for bronchoscopy.
Key exclusion criteria
Subjects are unable to give written consent.
Subjects who have not undergone bronchoscopy
Target sample size
5
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
Division of Respiratory Medicine, Center for Respiratory Medicine
Zip code
6128555
Address
1-1, Fukakusa-Mukaihata Fushimi, Kyoto
TEL
0756419161
kfujita.acd@gmail.com
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, Fushimi, Kyoto
TEL
0756419161
Homepage URL
kfujita.acd@gmail.com
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Kohei Fujita
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
HiLung
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1, Fukakusa-Mukaihata, Fushimi, Kyoto
Tel
0756419161
kfujita.acd@gmail.com
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
| 2023 | Year | 11 | Month | 01 | 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
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After the final enrolment of patients, the study is completed with a three-month follow-up.
Management information
Registered date
| 2023 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059727
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
