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

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-23
• Study Completion: 2018-03-01
• Last Update Posted: 17 October 2023

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.