UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054726 |
|---|---|
| Receipt number | R000062534 |
| Scientific Title | Epidemiology of non-cystic fibrosis bronchiectasis at a single center in Japan: a retrospective cohort study |
| Date of disclosure of the study information | 2024/06/21 |
| Last modified on | 2024/06/21 09:21:59 |
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Basic information
Public title
Real World Data in Bronchiectasis
Acronym
Real World Data in Bronchiectasis
Scientific Title
Epidemiology of non-cystic fibrosis bronchiectasis at a single center in Japan: a retrospective cohort study
Scientific Title:Acronym
Epidemiology of NCFBE at a single center in Japan: a retrospective cohort study
Region
| Japan |
Condition
Condition
non-cystic fibrosis bronchiectasis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the current status of bronchiectasis treatment by examining the epidemiology, course after diagnosis, and long-term prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Baseline characteristics, prognostic factors, and overall survival of patients with and without non-NTM infection were evaluated; effects of long-term macrolide antibiotic use in patients without severe exacerbations were estimated using inverse probability weighting (IPW).
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
1) Name of disease and diagnostic method: Patient underwent chest CT at our hospital at least once since 2012,
The patient has a finding of bronchiectasis on CT and the disease name of bronchiectasis has been confirmed.
2) Age: 18 years of age or older
3) Gender: Any gender
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kida |
Organization
Osaka Toneyama Medical Centre
Division name
Department of Respiratory Medicine
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka 560-8552, 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 University Graduate School of Medicine
Division name
Department of Respiratory Medicine and Clinical Immunology
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3831
Homepage URL
k.hashimoto@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Toneyama Medical Centre
Institute
Department
Personal name
Funding Source
Organization
AMED
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 Centre
Address
5-1-1 Toneyama, Toyonaka, Osaka 560-8552, Japan
Tel
06-6853-2001
None
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 | 06 | Month | 21 | 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
1044
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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Explanation and Consent
Since only existing information will be used in this study, written informed consent will be omitted by guaranteeing the opportunity to refuse. 2.
2. changes to the research plan
If there are any changes in the research plan after the ethical review approval, an application will be made to the Clinical Research Review Committee as soon as possible.
Unless the changes are minor and deemed unnecessary by the Clinical Research Review Committee and approved by the Director, explanation and consent based on the preceding paragraph will be given again.
3.Withdrawal of Consent
If a research subject withdraws his/her consent in writing, he/she will be excluded from the research.
Management information
Registered date
| 2024 | Year | 06 | Month | 21 | Day |
Last modified on
| 2024 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062534
