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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | peripheral pulmonary lesion | |
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
yumatsum@ncc.go.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |