Japan molecular epidemiology lung cancer cases study
Not Applicable
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000008177
- Lead Sponsor
- ational Hospital Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 900
Inclusion Criteria
Not provided
Exclusion Criteria
1. Prior chemotherapy or radiotherapy 2. Other prior malignancy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Assess lung tissue from patients with stage I, stage II, stage IIIA, or stage IIIB non-small cell lung cancer for alterations in specific genes, including EGFR, Kras and ALK, and for expression of HER2 and estrogen receptors and for detection of Human Papilloma virus (HPV), and for exploring new molecular markers using a next generation DNA sequencer. 2. Determine whether the frequency of EGFR, Kras and ALK mutations differ in lung cancer between never smokers and ever-smokers males and females. 3. Determine whether the frequency of EGFR mutations is higher in never smokers with exposed long duration of passive smoke than those with short one, divided by the median duration. 4. Determine whether the detection rate of HPV is higher in the southern part region than the northern in Japan.
- Secondary Outcome Measures
Name Time Method 1. Determine whether relapse rate, disease free survival and overall survival time differ among the patients with EGFR mutations, Kras and the any other. 2. Determine whether mutational profiles differ between Japanese and Americans adjusting by gender, smoking status and other clinical backgrounds.