UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Spectrum analysis of endobronchial ultrasound for the support of lymph node diagnosis during endobronchial ultrasound-guided transbronchial needle aspiration
Title of the study (Brief title)	Spectrum analysis of endobronchial ultrasound image
Region	Japan

Condition
Condition	Intrathoracic adenopathy
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical benefit of spectrum analysis of convex probe endobronchial ultrasound during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for the diagnosis of intrathoracic adenopathy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	In comparing each spectrum parameter and pathological results, the primary outcome measures will be; 1) Sensitivity, 2) Specificity, 3) Positive predictive value, 4) Negative predictive value, 5) Accuracy in detecting nodal metastasis
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	candidate for EBUS-TBNA
Key exclusion criteria	Inability to give informed consent.
Target sample size	250

Research contact person
Name of lead principal investigator	Ichiro Yoshino
Organization	Graduate School of Medicine, Chiba University
Division name	Department of General Thoracic Surgery
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Email	tnakajima76@hotmail.com

Public contact
Name of contact person	Takahiro Nakajima
Organization	Graduate School of Medicine, Chiba University
Division name	Department of General Thoracic Surgery
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Homepage URL
Email	takahiro.nakajima@chiba-u.jp

Sponsor
Institute	Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 31 Day
Anticipated trial start date	2013 Year 07 Month 10 Day
Last follow-up date	2015 Year 12 Month 31 Day
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	In comparing each spectrum parameter and pathological results, the primary outcome measures will be; 1) Sensitivity, 2) Specificity, 3) Positive predictive value, 4) Negative predictive value, 5) Accuracy in detecting nodal metastasis

Management information
Registered date	2013 Year 07 Month 03 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013007