UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054441 |
|---|---|
| Receipt number | R000062187 |
| Scientific Title | A Retrospective Observational Study on the Epidemiology of Patients with Bronchiectasis |
| Date of disclosure of the study information | 2024/05/20 |
| Last modified on | 2024/05/20 19:20:59 |
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Basic information
Public title
A Retrospective Observational Study on the Epidemiology of Patients with Bronchiectasis
Acronym
Obseervational Study on Bronchiectasis
Scientific Title
A Retrospective Observational Study on the Epidemiology of Patients with Bronchiectasis
Scientific Title:Acronym
Obseervational Study on Bronchiectasis
Region
| Japan |
Condition
Condition
Bronchiectasis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to gain a detailed understanding of the epidemiology and underlying conditions of bronchiectasis in Japan. This condition arises from various causes, with regional differences significantly influencing clinical presentation. However, specific epidemiological data and elucidating underlying diseases in Japan still need to be increased, necessitating clarification in these areas. Additionally, by including cases of bronchiectasis incidentally discovered through imaging diagnostics, the study aims to capture latent conditions with minimal symptoms, thereby providing a more accurate clinical picture. This approach is expected to enhance the understanding of cases with subtle symptoms and contribute to detecting undiagnosed or underestimated cases early.
Basic objectives2
Others
Basic objectives -Others
Furthermore, the study identifies cases suitable for developing ongoing bronchiectasis treatments. Proper case selection is crucial for evaluating the efficacy of new treatments, and identifying patient groups with disease backgrounds unique to Japan is a vital step in treatment development. By comparing these findings with those of other regions, such as Europe and the United States, the study also explores the potential for developing treatment methods unique to Japan. Thus, this research aims to contribute to advancing domestically and internationally bronchiectasis treatment, ultimately improving patients' quality of life.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The overall survival rate following the diagnosis of bronchiectasis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases with a history of chest CT scans diagnosed with bronchiectasis on imaging required outpatient visits or hospitalization between January 1, 2014, and December 31, 2023.
Key exclusion criteria
Cases not reviewed by a radiologist.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Shindo |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine,
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
+81-52-744-2167
shindo.yuichiro.y7@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsaku |
| Middle name | |
| Last name | Hayai |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine,
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
+81-52-744-2167
Homepage URL
hayai.shiyunsaku.x9@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
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
Observational Research Ethics Committee, Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
+81-52-744-2167
ethics@med.nagoya-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 | 05 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary Outcome:
- Overall survival rate following the diagnosis of bronchiectasis.
Secondary Outcomes:
- Number of hospitalizations
- Number of exacerbations
- Decline in lung function
- Decrease in quality of life (QOL)
- Changes in disease severity
Exposure/Predictive Factors:
It is hypothesized that the underlying conditions associated with bronchiectasis influence differences in treatment responsiveness and prognosis.
Additional Data to be Collected:
- Age at the time of bronchiectasis diagnosis
- Gender
- Comorbidities
- Details of treatment interventions
- Longitudinal lung function data from the first visit to the current follow-up at our hospital
- Blood test results
- Number of hospitalizations
- Number of exacerbations due to respiratory diseases
Data Collection Method:
- Extraction from electronic medical records.
Statistical Analysis Method:
- Descriptive statistics using summary measures.
Expected Results:
This study is expected to enable the investigation of the epidemiology of bronchiectasis in the Japanese population and provide an understanding of differences in underlying conditions compared to Western populations. By tracking the clinical course, a detailed understanding of the clinical characteristics of bronchiectasis patients under continuous follow-up at our hospital is anticipated. This is expected to lead to the provision of appropriate treatments.
Management information
Registered date
| 2024 | Year | 05 | Month | 20 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062187
