Genetics of EGFR (Epidermal Growth Factor Receptor) Mutation Study

EGFR Mutation Positive Non Small Cell Lung Cancer Clinical Trial

— GEM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01838577
• Other study ID #: EORTC-08114
• Status: Active, not recruiting
• Start date: September 2013
• Est. completion date: March 2022

Study information

• Verified date: March 2021
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• Histologically or cytologically diagnosed NSCLC, all histologies are acceptable.

• Patients can be included in the study with any disease stage and at any time during the disease course.

• Any type (surgery, RadioTherapy, chemotherapy, targeted agents) of previous treatment and any line of treatment are eligible.

• Age =18 years.

Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial.

Before patient registration, written informed consent must be given according to ICH/GCP (International Conference on Harmonisation/Good Clinical Practice), and national/local regulations.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Mutation Positive Non Small Cell Lung Cancer

Locations

Country	Name	City	State
United Kingdom	Royal Marsden	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For the second objective, the primary endpoint is Overall survival (OS)		5 years from FPI