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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000044676
Receipt No. R000050865
Scientific Title An observational study on diagnostic yield and the number of tumor cells of ultrathin bronchoscopy and thin bronchoscopy for peripheral lung lesions
Date of disclosure of the study information 2021/06/27
Last modified on 2021/07/06

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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