UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009991 |
|---|---|
| Receipt number | R000011699 |
| Scientific Title | Factors Related to Diagnostic Sensitivity of Transbronchial Biopsy Using Virtual Bonchoscopic Navigation and Endobronchial Ultrasonography with a Guide Sheath in Malignant Peripheral Pulmonary Lesions |
| Date of disclosure of the study information | 2013/02/07 |
| Last modified on | 2014/05/06 10:07:20 |
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Basic information
Public title
Factors Related to Diagnostic Sensitivity of Transbronchial Biopsy Using Virtual Bonchoscopic Navigation and Endobronchial Ultrasonography with a Guide Sheath in Malignant Peripheral Pulmonary Lesions
Acronym
Factors Related to Diagnostic Sensitivity of Transbronchial Biopsy Using Virtual Bonchoscopic Navigation and Endobronchial Ultrasonography with a Guide Sheath in Malignant Peripheral Pulmonary Lesions
Scientific Title
Factors Related to Diagnostic Sensitivity of Transbronchial Biopsy Using Virtual Bonchoscopic Navigation and Endobronchial Ultrasonography with a Guide Sheath in Malignant Peripheral Pulmonary Lesions
Scientific Title:Acronym
Factors Related to Diagnostic Sensitivity of Transbronchial Biopsy Using Virtual Bonchoscopic Navigation and Endobronchial Ultrasonography with a Guide Sheath in Malignant Peripheral Pulmonary Lesions
Region
| Japan |
Condition
Condition
Malignant peripheral pulmonary lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the indication of transbronchial biopsy using virtual bronchoscopic navigation combined with radial-type endobronchial ultrasonography and guide sheath in malignant peripheral pulmonary lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic sensitivity.
Key secondary outcomes
Correlation between diagnostic sensitivity and findings of CT and FDG-PET (lesion diameter, location of lesion, CT findings, relationship between the lesions and the bronchial tree, bronchial generation of VBN, and SUVmax of FDG-PET).
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
1.Small malignant peripheral pulmonary lesions of 30 mm>=
2.Not visible by bronchoscopy
3.20 or more than 20 years of age
4.Patients who underwent both CT and FDG-PET
Key exclusion criteria
1.Visible by bronchoscopy
2.Less than 20 years of age
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Umeda |
Organization
University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Fukui 910-1193 Japan
TEL
0776-61-3111
umeda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Umeda |
Organization
University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Fukui 910-1193 Japan
TEL
0776-61-3111
Homepage URL
umeda@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
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
Ishikawa Prefectural Central Hospital
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
福井大学医学部附属病院（福井県）、石川県立中央病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0169500214001469
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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 31 | Day |
Other
Other related information
Retrospective study
Management information
Registered date
| 2013 | Year | 02 | Month | 07 | Day |
Last modified on
| 2014 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011699
