UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026942 |
|---|---|
| Receipt number | R000030900 |
| Scientific Title | Prospective registry of diagnostic and interventional bronchoscopy subjects for quality improvement |
| Date of disclosure of the study information | 2017/04/12 |
| Last modified on | 2023/04/25 14:38:27 |
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Basic information
Public title
Prospective registry of diagnostic and interventional bronchoscopy subjects for quality improvement
Acronym
Prospective registry of bronchoscopy cases
Scientific Title
Prospective registry of diagnostic and interventional bronchoscopy subjects for quality improvement
Scientific Title:Acronym
Prospective registry of bronchoscopy cases
Region
| Japan |
Condition
Condition
Thoracic diseases that are indication for bronchoscopic diagnosis and treatment.
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this prospective registry is collecting the prospective data that relate with bronchoscopic diagnosis as well as treatment for quality improvement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnosis: sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy.
Treatment: successrate, complication rate
Overall: safety, procedure time, complication, utility of bronchoscopy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The candidates for bronchoscopic diagnosis and treatment with patient's consent.
Key exclusion criteria
Inability give informed consent.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yoshino |
Organization
Chiba University Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba 260-8677 JAPAN
TEL
043-222-7171
iyoshino@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Terunaga |
| Middle name | |
| Last name | Inage |
Organization
Chiba University Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba 260-8677 JAPAN
TEL
043-222-7171
Homepage URL
terunaga.inage@chiba-u.jp
Sponsor or person
Institute
Department of General Thoracic Surgery
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of General Thoracic Surgery Chiba University Graduate School of Medicine
Address
1-8-1, Inohana, Chuo-ku, Chiba 260-8677 JAPAN
Tel
043-222-7171
terunaga.inage@chiba-u.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
千葉大学大学院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 12 | 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
| 2017 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective registry related with bronchoscopic diagnosis and treatment for quality improvement.
Management information
Registered date
| 2017 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030900
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
