UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prospective observational study for researching the association between the survivals and the amount of malignant pleural effusion in patients of malignant pleuritis
Title of the study (Brief title)	The observational study for researching the association between the survivals and the amount of malignant pleural effusion
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	researching the association between the survivals and the amount of malignant pleural effusion in patients of malignant pleuritis
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	overall survival
Key secondary outcomes

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 with malignant pleulitis diagnosed pathologically or cytologically 2) patients with non-small cell lung cancer
Key exclusion criteria	1) patients with distant metastases 2) PS3 or 4 3) patients with heart or hepatic falure 4) patients with history of thoracotomy or hemorrhagic 5) patients with multiple cancers 6) patients with severe mental disorder 7) patients with severe thoracic adhesion
Target sample size	213

Research contact person
Name of lead principal investigator	Kohei Yokoi
Organization	Nagoya university school of medicine
Division name	department of thoracic surgery and respiratory medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2376
Email	shota197065@med.nagoya-u.ac.jp

Public contact
Name of contact person	Shota Nakamura
Organization	Nagoya university
Division name	department of thoracic surgery
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2376
Homepage URL
Email	shota197065@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya university
Institute
Department

Funding Source
Organization	Nagoya university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	central japan lung study group
Name of secondary funｄer(s)

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 01 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 10 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The depth is measured on CT as an amount of pleural effusion with patients with malignant pleuritis. and the patients were observed their survival.

Management information
Registered date	2015 Year 01 Month 08 Day
Last modified on	2018 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018761