UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Spectrum analysis of endobronchial ultrasound radiofrequency for the prediction of intrathoracic malignancy
Title of the study (Brief title)	endobronchial ultrasound spectrum analysis for the prediction of malignancy
Region	Japan

Condition
Condition	intrathoracic tumor including lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop the prediction system for intrathoracic malignant by analyzing endobronchail ultrasound radiofrequency.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy by using the specific spectrum value (slope, mid-band fit, intercept) during endobronchial ultrasound.
Key secondary outcomes	Measurement of ultrasonic spectral parameters during endobronchial ultrasound.

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	Candidates for endobronchial ultrasonography.
Key exclusion criteria	Inability to give informed consent.
Target sample size	250

Research contact person
Name of lead principal investigator	Takahiro Nakajima
Organization	Chiba University Graduate School of Medicine
Division name	Department of General Thoracic Surgery
Address	1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL	043-222-7171
Email	takahiro_nakajima@med.miyazaki-u.ac.jp

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

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Japan Society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2017 Year 04 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 14 Day
Anticipated trial start date	2017 Year 04 Month 14 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	1. Measurement of ultrasonic spectral parameters during endobronchial ultrasound and prospectively recorded independently that blind to pathologists. 2. Compare the results between prediction by spectrum parameters and pathological diagnosis. 3. Analysis of sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of spectrum parameters.

Management information
Registered date	2017 Year 04 Month 10 Day
Last modified on	2018 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030897