UMIN-CTR Clinical Trial

Basic information
Public title	A prospective cohort study: probe based confocal laser endomicroscopy for peripheral pulmonary lesions
Acronym	pCLE prospective cohort study
Scientific Title	A prospective cohort study: probe based confocal laser endomicroscopy for peripheral pulmonary lesions
Scientific Title:Acronym	pCLE prospective cohort study
Region	Japan

Condition
Condition	peripheral pulmonary lesion
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Assess efficacy of probe based confocal laser endomicroscopy (pCLE) for peripheral pulmonary lesions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	assessment for achievement
Key secondary outcomes	discrimination of malignancy

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) with a peripheral pulmonary lesion (PPL) that is suspecterd lung cancer by thin-section computed tomography (TSCT) 2) going to examine bronchoscopy with navigation, endobronchial ultrasound with a guide sheath, X-ray fluoroscopy and pCLE 3) obtained comprehensive agreement for study
Key exclusion criteria	1) without TSCT before bronchoscopy 2) a poorly-marginated lesion as a PPL 3) multiple PPLs in a case 4) intend to re-biopsy 5) SpO2 less than 90% 6) uncontrolled condition such as angina, myocardial infarction, severe bronchial asthma, active lung infection, low respiratory function, heart failure, bleeding tendency, and so on 7) during pregnancy 8) after pacemaker fitted 9) anticoagulants or antiplatelet agents can not be stopped for 3 days or more 10) difficult to get agreement by the document 11) other inappropriate reasons
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Matsumoto
Organization	National Cancer Center Hospital
Division name	Department of Endoscopy, Respiratory Endoscopy Division
Zip code	104-0045
Address	5-1-1, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	yumatsum@ncc.go.jp

Public contact
Name of contact person	1st name Matsumoto Middle name Last name Yuji
Organization	National Cancer Center Hospital
Division name	Department of Endoscopy, Respiratory Endoscopy Division
Zip code	104-0045
Address	5-1-1, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Homepage URL
Email	yumatsum@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	National Cancer Center Research and Development Fund
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	National Cancer Center Institutional Review Board
Address	5-1-1, Chuo-ku, Tokyo, Japan
Tel	03-3542-2511
Email	irst@ml.res.ncc.go.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	2015 Year 06 Month 01 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
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	2015 Year 05 Month 21 Day
Date of IRB	2015 Year 05 Month 21 Day
Anticipated trial start date	2015 Year 06 Month 04 Day
Last follow-up date	2016 Year 09 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a prospective cohort study to assess the utility of probe based confocal laser endomicroscopy (pCLE) in bronchoscopy for peripheral pulmonary lesions.

Management information
Registered date	2015 Year 05 Month 31 Day
Last modified on	2020 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020538

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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