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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024170
Receipt No. R000027829
Scientific Title A prospective observational study: the utility of flex-rigid pleuroscopy for malignant pleural disease
Date of disclosure of the study information 2016/09/27
Last modified on 2016/09/26

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Basic information
Public title A prospective observational study: the utility of flex-rigid pleuroscopy for malignant pleural disease
Acronym Pleuroscopy prospective observational study
Scientific Title A prospective observational study: the utility of flex-rigid pleuroscopy for malignant pleural disease
Scientific Title:Acronym Pleuroscopy prospective observational study
Region
Japan

Condition
Condition malignant pleural disease
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of flex-rigid pleuroscopy for malignant pleural disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnostic yield
Key secondary outcomes 1) safety
2) feasibility of molecular analysis

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
99 years-old >=
Gender Male and Female
Key inclusion criteria 1) Cases that is suspected to have pleural malignant disease by computed tomography (CT)
2) Cases that is required re-biopsy and tissue specimen for the recurrence of pleural malignant disease
3) Obtained comprehensive agreement for study
Key exclusion criteria 1) without CT before pleuroscopy
2) with severe pleural adhesions
3) severe respiratory failure of the contralateral lung
4) cases that can not quietly lie
5) SpO2 less than 90%
6) uncontrolled condition such as angina, myocardial infraction, severe bronchial asthmna, active lung infection, heart failure, bleeding tendency, and so on
7) during pregnancy
8) anticoagulants or antiplatelet agents can not be stopped for 3 days or more
9) difficult to get agreement by the document
10) other inappropriate reasons
Target sample size 25

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

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Nakai
Organization National Cancer Center Hospital
Division name Endoscopy Division
Zip code
Address 5-1-1, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email tnakai@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization The 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
Address
Tel
Email

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
2016 Year 09 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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the efficacy of flex-rigid pleuroscopy for malignant pleural disease

Management information
Registered date
2016 Year 09 Month 26 Day
Last modified on
2016 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027829

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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