UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of B-type natriuretic peptide in predicting postoperative complications following pulmonary resection for non-small lung cancer patients with induction chemotherapy
Title of the study (Brief title)	Utility of BNP in predicting postoperative complications following pulmonary resection with induction chemotherapy
Region	Japan

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

Objectives
Narrative objectives1	The objective of the present study is to evaluate the utility of BNP in predicting postoperative complications following pulmonary resection for non-small lung cancer patients with induction chemotherapy.
Basic objectives2	Others
Basic objectives -Others	The objective of the present study is to evaluate the utility of BNP in predicting postoperative complications following pulmonary resection for non-small lung cancer patients with induction
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The correlation with postoperative complications and the change of BNP levels
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The non-small lung cancer patients undergoing pulmonary resection with induction chemotherapy
Key exclusion criteria	None
Target sample size	15

Research contact person
Name of lead principal investigator	Takashi Nojiri
Organization	National Toneyama Hospital
Division name	General Thoracic Surgery
Address	Toneyama 5-1-1, Toyonaka City, Osaka, Japan
TEL	06-6853-2001
Email	nojirit@thoracic.med.osaka-u.ac.jp

Public contact
Name of contact person	Takashi Nojiri
Organization	National Toneyama Hospital
Division name	General Thoracic Surgery
Address	Toneyama 5-1-1, Toyonaka City, Osaka, Japan
TEL	06-6853-2001
Homepage URL
Email	nojirit@thoracic.med.osaka-u.ac.jp

Sponsor
Institute	Department of General Thoracic Surgery, National Hospital Organization National Toneyama Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	国立病院機構刀根山病院

Other administrative information
Date of disclosure of the study information	2010 Year 01 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2007 Year 07 Month 01 Day
Anticipated trial start date	2007 Year 07 Month 01 Day
Last follow-up date	2013 Year 03 Month 01 Day
Date of closure to data entry	2013 Year 06 Month 01 Day
Date trial data considered complete	2014 Year 03 Month 01 Day
Date analysis concluded	2015 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Evaluate the correlation the changes of BNP levels and the incidence of postoperative complications

Management information
Registered date	2010 Year 01 Month 10 Day
Last modified on	2016 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003646