GEM (EORTC 08114)
Research type
Research Study
Full title
Genetics of EGFR Mutation Study (GEM): a Translational Study of the EORTC Lung Group.
IRAS ID
136783
Contact name
Fiona Blackhall
Contact email
Sponsor organisation
EORTC
Research summary
This is a prospective translational research study.
The purpose of this study is to identify genetic factors that increase the risk of developing Epidermal Growth Factor Receptor (EGFR) mutant lung cancer and to see whether these factors influence lung cancer outcome. In particular we are looking to identify segments of lung cancer genetic code (DNA) that increases the risk of developing of two specific types of non-small cell lung cancer (NSCLC):
♦ NSCLC where the tumor has a mutation in a gene called EGFR (usually this is tested routinely in your hospital) ’EGFR mutant lung cancer’
♦ NSCLC where this mutation in EGFR is not found but patients have never smoked (less than 100 cigarettes in lifetime) or have previously only smoked very lightly (stopped smoking more than 1 year ago and smoked less than 10 pack-years).
For reasons that are currently unclear, these ’EGFR mutant’ cancers are more frequently seen in the type of NSCLC called adenocarcinoma. They tend to occur more frequently in women, and are seen more frequently in patients of East Asian (e.g. Chinese) ethnic origin. The reasons why these cancers occur more frequently in these individuals than in the general population are unknown.About 2000 participants will take part in this study. Half of these patients will have NSCLC with a mutation in the EGFR gene, while the other half will have NSCLC without mutations in that gene and at the same time be never smoker (less than 100 cigarettes in lifetime) or ex-light smoker (stopped smoking more than 1 year ago and smoked less than 10 pack-years).
A blood sample will be taken from each participant for analysis. Relevant medical history and demographic information will be collected. Participants will also be asked to complete a lifestyle questionnaire.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
14/YH/0062
Date of REC Opinion
25 Feb 2014
REC opinion
Favourable Opinion