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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004360
Receipt No. R000005214
Scientific Title a study for association between environmental tobacco smoke exposure and EGFR and KRAS mutations in never smokers with non-small cell lung cancer
Date of disclosure of the study information 2010/10/08
Last modified on 2016/04/13

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Basic information
Public title a study for association between environmental tobacco smoke exposure and EGFR and KRAS mutations in never smokers with non-small cell lung cancer
Acronym ETS and EGFR study
Scientific Title a study for association between environmental tobacco smoke exposure and EGFR and KRAS mutations in never smokers with non-small cell lung cancer
Scientific Title:Acronym 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

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 never smokers with NSCLC
Key exclusion criteria nothing particulr
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoya Kawaguchi
Organization NHO Kinki-chuo Chest Medical Center
Division name Internal Medicine
Zip code
Address 1180 Nagasone-cho, Sakai, Osaka591-8555, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization NHO Kinki-chuo Chest Medical Center
Division name Internal Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute NHO Kinki-chuo Chest Medical Center
Institute
Department

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)

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

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2008 Year 02 Month 18 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000005214

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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