UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001334 |
|---|---|
| Receipt number | R000001620 |
| Scientific Title | Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with vs. without rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer |
| Date of disclosure of the study information | 2008/08/25 |
| Last modified on | 2014/06/11 09:36:57 |
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Basic information
Public title
Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with vs. without rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer
Acronym
Comparison of EBUS-TBNA with vs. without ROSE
Scientific Title
Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with vs. without rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer
Scientific Title:Acronym
Comparison of EBUS-TBNA with vs. without ROSE
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the utility of ROSE on EBUS-TBNA in the diagnosis of lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
1. Yields for eliminating the need for additional bronchoscopic procedures
Key secondary outcomes
1. Diagnostic yields (EBUS-TBNA, overall bronchoscopy)
2. Accuracy of EBUS-TBNA
3. Number of needle passes
4. Time of procedure (EBUS-TBNA, overall bronchoscopy)
5. Accuracy of ROSE
6. Frequency of adverse effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EBUS-TBNA with ROSE
Interventions/Control_2
EBUS-TBNA without ROSE
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. Patients suspected to have lung cancer with enlarged mediastinal and/or hilar lesions 10 mm or greater in short-axis diameter on CT
2. 20 years old or more
3. Informed consent
Key exclusion criteria
1. Patients with known lung cancer (e.g., mediastinal staging purposes)
2. Endobronchial lesions
3. Patients with severe concomitant medical illness
4. Bleeding tendency
5. Pregnant woman
6. Other clinical difficulties in this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Oki |
Organization
Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahide Oki |
Organization
Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
Homepage URL
masahideo@aol.com
Sponsor or person
Institute
Nagoya Medical Center
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
| 2008 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.karger.com/Article/FullText/346987
Number of participants that the trial has enrolled
Results
Twelve patients with visible endobronchial lesions were excluded in the analysis. Thus, a total of 108 patients (55 in ROSE group; 53 in non-ROSE group) were analyzed. Additional procedures including EBUS-TBNA for lesions other than the main target lesion and/or transbronchial biopsy in the same setting were performed in 11% of patients in the ROSE group and 57% in the non-ROSE group (p < 0.001). Mean puncture number was significantly fewer in the ROSE group (2.2 vs. 3.1 punctures, p < 0.001). Mean bronchoscopy time was similar between both groups (22.3 vs. 22.1 min, p = 0.95). The sensitivity and accuracy for diagnosing lung cancer were 88% and 89% in the ROSE group, and 86% and 89% in the non-ROSE group, respectively. No complications were associated with the procedures.
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
| 2008 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | 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
| 2008 | Year | 08 | Month | 22 | Day |
Last modified on
| 2014 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001620
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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