UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-institutional study of immunologic response tu surgical stress in patients undergoing pulmonary lobectomy
Title of the study (Brief title)	Immunologic response to surgical stress of lobectomy
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate an immunologic response according to trauma size paitents undergoing pulmonary lobectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between trauma size and short-term outcome including immunologic response and morbidity
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	Need for lobectomy That consent is obtained
Key exclusion criteria	The person in charge ise determined to be inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	Risa Oda
Organization	Nagoya City University
Division name	Department of Oncology,Immunology and Surgery
Address	1 kawasumi,mizuho-cho,mizuho-ku,Nagoya,Aichi,Japan
TEL	052-853-8231
Email	pear_pear111@yahoo.co.jp

Public contact
Name of contact person	Risa Oda
Organization	Nagoya City University
Division name	Department of Oncology,Immunology and Surgery
Address	1 kawasumi,mizuho-cho,mizuho-ku,Nagoya,Aichi,Japan
TEL	052-853-8231
Homepage URL
Email	pear_pear111@yahoo.co.jp

Sponsor
Institute	Nagoya City University
Institute
Department

Funding Source
Organization	Nagoya City University
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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 08 Day
Anticipated trial start date	2016 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	object:patiants who underwent lobectomy for clinical stage 1A lung cancer. measurement item:IL-4,6,8,10,Hb,WBC,Plt,CRP etc.

Management information
Registered date	2016 Year 02 Month 24 Day
Last modified on	2018 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024425