NCT01838577

Genetics of EGFR (Epidermal Growth Factor Receptor) Mutation Study

Genetics of EGFR Mutation Study (GEM): a Translational Study of the EORTC Lung Group.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators wish to document the distribution of EGFR somatic mutations, and assess the relationship between specific genotype, clinical demographic, therapy, and survival, in a large cohort of EGFR mutant NSCLC. The investigators also wish to comprehensively investigate the relationship between germline DNA and risk of EGFR mutant NSCLC developing, through a GWAS (Genome-Wide Association Studies) and candidate gene approach, and explore the relationship between germline DNA and clinical outcome, in order to potentially identify germline genetic modifiers of EGFR TKI (Tyrosine Kinase Inhibitor) outcome.

Detailed description

Objective 1: To identify germline allelic DNA variation associated with somatic EGFR mutation in NSCLC, Objective 2: Correlation between germline allelic variants and survival in EGFR somatic mutant NSCLC. Objective 3: Study germline allelic DNA variation associated with never /ex light smoking NSCLC. Objective 4: Catalogue distribution of somatic EGFR mutant genotypes in 1,000 EGFR mutant NSCLC cases and describe their relationship to clinical outcome.

Conditions

• EGFR Mutation Positive Non Small Cell Lung Cancer

Timeline

• Start date: 2013-09-01
• Primary completion: 2021-12-01
• Completion: 2022-03-01
• First posted: 2013-04-24
• Last updated: 2021-03-09

Locations

1 site across 1 country: United Kingdom