UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective observational study about frequency and chest CT finding of a common trunk of the left pulmonary vein in the lung cancer surgery
Acronym	Retrospective observational study about frequency and chest CT finding of a common trunk of the left pulmonary vein in the lung cancer surgery
Scientific Title	Retrospective observational study about frequency and chest CT finding of a common trunk of the left pulmonary vein in the lung cancer surgery
Scientific Title:Acronym	Retrospective observational study about frequency and chest CT finding of a common trunk of the left pulmonary vein in the lung cancer surgery
Region	Japan

Condition
Condition	A common trunk of the left pulmonary vein
Classification by specialty	Chest surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the present study is to identify the frquency of a common trunk of the left pulmonary vein in the patients who underwent anatomical lung resection for the left lung cancer by retrospective study.The secondary object is To establish the preoperative diagnostic method of a common trunk of the left pulmonary vein in the axial view of CT
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To identify the frquency of a common trunk of the left pulmonary vein in the lung cancer surgery
Key secondary outcomes	To establish the preoperative diagnostic method of a common trunk of the left pulmonary vein in the axial view of CT

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	From January 2013 to December 2017, all the patients who underwent thin-section (1-mm collimation) chest CT preoperatively and anatomic lung resection for left lung cancer at Nagoya City University Hospital, Suzuka Chuo General Hospital, Toyota Memorial Hospital, and Nagoya City West Medical Center were included.
Key exclusion criteria	none
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Keisuke Middle name Last name Yokota
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Oncology, Immunology and Surgery
Zip code	467-8602
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
TEL	0528538231
Email	keyokota@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Keisuke Middle name Last name Yokota
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Oncology, Immunology and Surgery
Zip code	467-8602
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
TEL	0528538231
Homepage URL
Email	yokota1025@hotmail.co.jp

Sponsor
Institute	Department of Oncology, Immunology and Surgery, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	none
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	Department of Oncology, Immunology and Surgery, Nagoya City University Graduate School of Medical Sciences
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
Tel	0528538231
Email	keyokota@med.nagoya-cu.ac.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	2019 Year 09 Month 01 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	428
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	2018 Year 10 Month 03 Day
Date of IRB	2018 Year 10 Month 03 Day
Anticipated trial start date	2018 Year 10 Month 03 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2019 Year 08 Month 08 Day
Last modified on	2019 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042903