UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Transbronchial Cryobiopsy Samples with Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Samples in Adequacy for Next-Generation Sequencing Analysis
Acronym	Comparison of Transbronchial Cryobiopsy Samples with Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Samples in Adequacy for Next-Generation Sequencing Analysis
Scientific Title	Comparison of Transbronchial Cryobiopsy Samples with Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Samples in Adequacy for Next-Generation Sequencing Analysis
Scientific Title:Acronym	Comparison of Transbronchial Cryobiopsy Samples with Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Samples in Adequacy for Next-Generation Sequencing Analysis
Region	Japan

Condition
Condition	lung caner
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	I order to report comparison of TBLC samples with EBUS-TBNA samples in adequacy for NGS analysis in clinical practice.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The adequacy for NGS analysis in TBLC samples.
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	This retrospective cohort study included patients whose lung samples were analyzed by NGS system for detecting driver gene mutations between June 2019 and July 2020 at the Japanese Red Cross Medical Center. The lung samples were collected by TBLC or EBUS-TBNA at our institution.
Key exclusion criteria	The lung samples were collected by other procedures than TBLC and EBUS-TBNA.
Target sample size	37

Research contact person
Name of lead principal investigator	1st name Mari Middle name Last name Tone
Organization	Japanese Red Cross Medical Center
Division name	Department of Respiratory Medicine
Zip code	150-8935
Address	4-1-22 Hiroo, Shibuya, Tokyo
TEL	03-3400-1311
Email	m.tone.0829@gmail.com

Public contact
Name of contact person	1st name Mari Middle name Last name Tone
Organization	Japanese Red Cross Medical Center
Division name	Department of Respiratory Medicine
Zip code	150-8935
Address	4-1-22 Hiroo, Shibuya, Tokyo
TEL	03-3400-1311
Homepage URL
Email	m.tone.0829@gmail.com

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Japanese Red Cross Medical Center
Address	4-1-22 Hiroo, Shibuya, Tokyo
Tel	03-3400-1311
Email	m.tone.0829@gmail.com

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	2020 Year 09 Month 05 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	37
Results
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	2019 Year 06 Month 01 Day
Date of IRB	2020 Year 05 Month 20 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is an observational study with no intervention. We collected data from patients' medical charts.

Management information
Registered date	2020 Year 09 Month 05 Day
Last modified on	2020 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047599