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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017757
Receipt No. R000020538
Scientific Title A prospective cohort study: probe based confocal laser endomicroscopy for peripheral pulmonary lesions
Date of disclosure of the study information 2015/06/01
Last modified on 2020/05/12

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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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