UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	a study for association between environmental tobacco smoke exposure and EGFR and KRAS mutations in never smokers with non-small cell lung cancer
Title of the study (Brief title)	ETS and EGFR study
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	to assess association between cumulative dose of ETS and development of EGFR and KRAS mutations
Basic objectives2	Others
Basic objectives -Others	molecular epidemiology
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	association between cumulative dose of ETS and development of EGFR and KRAS mutations
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	never smokers with NSCLC
Key exclusion criteria	nothing particulr
Target sample size	300

Research contact person
Name of lead principal investigator	Tomoya Kawaguchi
Organization	NHO Kinki-chuo Chest Medical Center
Division name	Internal Medicine
Address	1180 Nagasone-cho, Sakai, Osaka591-8555, Japan
TEL
Email

Public contact
Name of contact person
Organization	NHO Kinki-chuo Chest Medical Center
Division name	Internal Medicine
Address
TEL
Homepage URL
Email

Sponsor
Institute	NHO Kinki-chuo Chest Medical Center
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	NHO Kinki-chuo Chest Medical Center
Organization
Division
Category of Funding Organization	Other
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	2010 Year 10 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 02 Month 18 Day
Anticipated trial start date	2008 Year 02 Month 01 Day
Last follow-up date	2016 Year 04 Month 13 Day
Date of closure to data entry	2016 Year 04 Month 13 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	This study is to examine molecular markers in never-smokers with NSCLC

Management information
Registered date	2010 Year 10 Month 08 Day
Last modified on	2016 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005214