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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000506
Receipt No. 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

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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
Email

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
Email Masahideo@aol.com

Sponsor
Institute Nagoya Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000614

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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