UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019014 |
|---|---|
| Receipt number | R000021985 |
| Scientific Title | A randomized control study - an efficacy of a virtual bronchoscopy made by the workstation for diagnostic bronchoscopy for peripheral pulmonary lesions - |
| Date of disclosure of the study information | 2015/09/18 |
| Last modified on | 2020/05/12 11:25:00 |
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Basic information
Public title
A randomized control study - an efficacy of a virtual bronchoscopy made by the workstation for diagnostic bronchoscopy for peripheral pulmonary lesions -
Acronym
Randomized Controlled Trial using ziostation (zio-RCT)
Scientific Title
A randomized control study - an efficacy of a virtual bronchoscopy made by the workstation for diagnostic bronchoscopy for peripheral pulmonary lesions -
Scientific Title:Acronym
Randomized Controlled Trial using ziostation (zio-RCT)
Region
| Japan |
Condition
Condition
peripheral pulmonary lesions
Classification by specialty
| Pneumology | Chest surgery | Radiology |
| Laboratory medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess an efficacy of a virtual bronchoscopy made by the workstation for diagnostic bronchoscopy for peripheral pulmonary lesions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
endobronchial ultrasound (EBUS) detection rate
Key secondary outcomes
diagnostic accuracy
examination time
safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Case group: diagnostic bronchoscopy with the virtual bronchoscopy made by the workstation
Interventions/Control_2
Control group: diagnostic bronchoscopy without the virtual bronchoscopy made by the workstation
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
1) patient with a peripheral pulmonary lesion (PPL) that is detected by thin-section computed tomography (TSCT) and its major diameter is 30mm or less
2) primary lung cancer is suspected by TSCT
3) patient is 20 years-old or more
4) written consent has been obtained with respect to participation in this study
Key exclusion criteria
1) benign tumor or inflammatory lesion is suspected by TSCT
2) PPL contains ground-glass opacity by TSCT
3) metastatic lung tumor is strongly suspected by medical history
4) re-biopsy is aimed
5) percutaneous oxygen saturation of patient is 90% or less in room air
6) patient has complications of poorly controled
7) patient is pregnant
8) patient inplants a pacemaker
9) patient cannot stop anticoagulant and antiplatelet drugs for 3 days or more
10) written consent has not been obtained
11) other reasons that attending physician deems patient inappropriate
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Matsumoto |
Organization
National Cancer Center Hospital
Division name
Department of Endoscopy, Respiratory Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
yumatsum@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Matsumoto |
Organization
National Cancer Center Hospital
Division name
Department of Endoscopy, Respiratory Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
http://www.ncc.go.jp/jp/about/rinri/study/kadai_h27.html
yumatsum@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
irst@ml.res.ncc.go.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
国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉県）、国立病院機構姫路医療センター（兵庫県）、亀田総合病院（千葉県）、千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 18 | 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
| 2015 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 14 | Day |
Last modified on
| 2020 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021985
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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