UMIN-CTR Clinical Trial

Basic information
Public title	An observational study on diagnostic yield and the number of tumor cells of ultrathin bronchoscopy and thin bronchoscopy for peripheral lung lesions
Acronym	An observational study on diagnostic yield and the number of tumor cells of ultrathin bronchoscopy and thin bronchoscopy for peripheral lung lesions
Scientific Title	An observational study on diagnostic yield and the number of tumor cells of ultrathin bronchoscopy and thin bronchoscopy for peripheral lung lesions
Scientific Title:Acronym	An observational study on diagnostic yield and the number of tumor cells of ultrathin bronchoscopy and thin bronchoscopy for peripheral lung lesions
Region	Japan

Condition
Condition	peripheral lung lesions
Classification by specialty	Pneumology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the number of tumor cells, diagnostic yield, number of biopsies, how many specimens were diagnosed first, and success rate of Oncomine analysis in cases of non-small cell lung cancer diagnosed using the ultrathin bronchoscope (MP290F) under radial EBUS with cases using the thin bronchoscope with specimens collected using the EBUS-GS method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of tumor cells of the specimens with the highest tumor content in non-small cell lung cancer cases
Key secondary outcomes	1) diagnosis yield 2) histopathological diagnosis 3) number of biopsies 4) number of biopsies with first diagnosis 5) Oncomine analysis success rate 6) percentage of PD-L1 evaluable 7) number of tumor cells per biopsy 8) percentage of tumor cells

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 who are 20 years old or older 2) patients whose medical information can be obtained from the medical record 3) patients who have undergone ultrathin bronchoscopy or thin bronchoscopy for peripheral lung lesions
Key exclusion criteria	patients who have requested not to participate in this study based on published information
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Motoko Middle name Last name Tachihara
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine,Department of Internal Medicine
Zip code	650-0017
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	+81-78-382-5660
Email	mt0318@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Atsuhiko Middle name Last name Yatani
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	+81-78-382-5660
Homepage URL
Email	ayatani@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Kobe University
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	Institutional Review Board, Kobe University Hospital Clinical Translational Research Center
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
Tel	078-382-6669
Email	kansatsu@med.kobe-u.ac.jp

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	2021 Year 06 Month 27 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	77
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	Terminated
Date of protocol fixation	2021 Year 05 Month 24 Day
Date of IRB	2021 Year 08 Month 16 Day
Anticipated trial start date	2021 Year 06 Month 27 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Primary outcomes The number of tumor cells of the specimens with the highest tumor content in non-small cell lung cancer cases Key secondary outcomes 1) diagnosis yield 2) histopathological diagnosis 3) number of biopsies 4) number of biopsies with first diagnosis 5) Oncomine analysis success rate 6) percentage of PD-L1 evaluable 7) number of tumor cells per biopsy 8) percentage of tumor cells

Management information
Registered date	2021 Year 06 Month 27 Day
Last modified on	2021 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050865