UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000506 |
|---|---|
| Receipt number | R000000614 |
| Scientific Title | A phase II study of real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer |
| Date of disclosure of the study information | 2006/11/01 |
| Last modified on | 2013/01/02 06:26:13 |
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Basic information
Public title
A phase II study of real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer
Acronym
EBUS-TBNA with ROSE in the diagnosis of lung cancer
Scientific Title
A phase II study of real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer
Scientific Title:Acronym
EBUS-TBNA with ROSE in the diagnosis of lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the diagnostic utility of EBUS-TBNA with ROSE in patients with suspected lung cancer presenting with enlarged hilar-mediastinal nodes or tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Diagnostic yield
Key secondary outcomes
1. Frequency of adverse effects 2. The accuracy of EBUS-TBNA for diagnosing malignancy 3. The accuracy of ROSE for predicting final diagnosis of malignancy
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. Patients with suspected malignancy who need to undergo diagnostic bronchoscopy 2. Hilar-mediastinal lesions 10 mm or greater in short-axis diameter on chest computed tomography 3. 20 years and above 4. Informed consent
Key exclusion criteria
1. Patients with known lung cancer 2. Pregnancy 3. Other clinical difficulties in this study
Target sample size
110
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
Cancer Research, Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
国立病院機構名古屋医療センター
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 11 | Month | 01 | 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
EBUS-TBNA with ROSE for hilar-mediastinal lesions established a specific diagnosis in 63 of all 81 patients (78%) examined, and in 55 of 64 (86%) in whom lung cancer was diagnosed without any complications. The ROSE results allowed the avoidance of additional bronchoscopic procedures in 53 of 81 patients (65%). Although four false-positive results and two false-negative results (accuracy; 93%) occurred in predicting the final diagnosis of malignancy by ROSE on EBUS-TBNA, the misdiagnosis by ROSE did not cause any significant adverse effects on patient care.
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
| 2004 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of the utility of EBUS-TBNA utilizing ROSE for diagnosis in patients with enlarged hilar-mediastinal lesions suspected of lung cancer
Management information
Registered date
| 2006 | Year | 10 | Month | 30 | Day |
Last modified on
| 2013 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000614
