UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To assess the usefulness of new EBUS-TBNA needle.
Title of the study (Brief title)	To assess the usefulness of new EBUS-TBNA needle.
Region	Japan

Condition
Condition	Non-small cell lung cancer with advanced stage
Classification by specialty	Medicine in general Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of new EBUS-TBNA needle.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Yields of adequate tissue specimen sampling
Key secondary outcomes

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 enlarged mediastinal and/or hilar lesions 10 mm or greater in short-axis diameter on CT or FDG uptaken 2.5 or higher in PET/CT imaging requiring diagnostic EBUS-TBNA 2. 20 years old and above 3. Informed consent
Key exclusion criteria	1.Patients requiring EBUS-TBNA for N-stage in patients with lung cancer 2.Serious concomitant medical illness
Target sample size	40

Research contact person
Name of lead principal investigator	Toshiyuki Nakai
Organization	National Cancer Center Hospital
Division name	Department of Endoscopy, Respiratory Endoscopy Division
Address	5-1-1, Tukiji Chou-ku, Tokyo, Japan
TEL	03-3542-2511
Email	tnakai@ncc.go.jp

Public contact
Name of contact person	Toshiyuki Nakai
Organization	National Cancer Center Hospital
Division name	Department of Endoscopy, Respiratory Endoscopy Division
Address	5-1-1, Tukiji Chou-ku, Tokyo, Japan
TEL	03-3542-2511
Homepage URL
Email	tnakai@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	The National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 02 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 02 Month 12 Day
Anticipated trial start date	2018 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The trial does not start.

Management information
Registered date	2018 Year 02 Month 14 Day
Last modified on	2018 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035724