UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001985 |
|---|---|
| Receipt number | R000002295 |
| Scientific Title | Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after Endobronchial ultrasonography (EBUS) introduction |
| Date of disclosure of the study information | 2009/05/25 |
| Last modified on | 2010/08/02 19:04:20 |
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Basic information
Public title
Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after Endobronchial ultrasonography (EBUS) introduction
Acronym
Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after Endobronchial ultrasonography (EBUS) introduction
Scientific Title
Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after Endobronchial ultrasonography (EBUS) introduction
Scientific Title:Acronym
Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after Endobronchial ultrasonography (EBUS) introduction
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endobronchial ultrasonography (EBUS) has been used in diagnosing peripheral lung cancer and has allowed for higher rates of peripheral lung cancer diagnosis, but few studies have reported that fluoroscopy time is shorted by the use of EBUS. Therefore, this study is a
retrospective study on shorting fluoroscopy time using EBUS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups before and after EBUS introduction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Discussion of the rate of diagnosis and fluoroscopy time in lung cancer in groups before EBUS introduction during twenty-one months
Interventions/Control_2
Comparison of the rate of diagnosis and fluoroscopy time in lung cancer in groups after EBUS introduction during twenty-one months
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases diagnosed as lung cancer by bronchoscope
Key exclusion criteria
Cases judged that method of bronchoscope is difficult
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Fujita |
Organization
St Marianna University school of Medicine
Division name
Division of Respiratory and Infectious Diseases Department of Internal Medicine
Zip code
Address
2-16-1 Sugao Miyamaeku Kawasaki Kanagawa Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
St Marianna University school of Medicine
Division name
Division of Respiratory and Infectious Diseases Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
St Marianna University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2009 | Year | 05 | Month | 25 | 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
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 19 | Day |
Last modified on
| 2010 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002295
