Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01838577
Status:
UNKNOWN
Last Update Posted:
2021-03-09
First Post:
2013-04-19
Brief Title:
Genetics of EGFR Epidermal Growth Factor Receptor Mutation Study
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Genetics of EGFR Mutation Study GEM a Translational Study of the EORTC Lung Group
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEM
Brief 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
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 1000 EGFR mutant NSCLC cases and describe their relationship to clinical outcome
Objective 3 Study germline allelic DNA variation associated with never ex light smoking NSCLC
Objective 4 Catalogue distribution of somatic EGFR mutant genotypes in 1000 EGFR mutant NSCLC cases and describe their relationship to clinical outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None