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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003011
Receipt No. R000003646
Scientific Title Utility of B-type natriuretic peptide in predicting postoperative complications following pulmonary resection for non-small lung cancer patients with induction chemotherapy
Date of disclosure of the study information 2010/01/10
Last modified on 2016/07/15

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Basic information
Public title Utility of B-type natriuretic peptide in predicting postoperative complications following pulmonary resection for non-small lung cancer patients with induction chemotherapy
Acronym Utility of BNP in predicting postoperative complications following pulmonary resection with induction chemotherapy
Scientific Title Utility of B-type natriuretic peptide in predicting postoperative complications following pulmonary resection for non-small lung cancer patients with induction chemotherapy
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Takashi Nojiri
Organization National Toneyama Hospital
Division name General Thoracic Surgery
Zip code
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
1st name
Middle name
Last name Takashi Nojiri
Organization National Toneyama Hospital
Division name General Thoracic Surgery
Zip code
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

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)

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 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

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
2007 Year 07 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000003646

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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