Genetics of EGFR (Epidermal Growth Factor Receptor) Mutation Study | Recruiting
Genetics of EGFR (Epidermal Growth ... | Recruiting
Genetics of EGFR (Epidermal Growth Factor Receptor) Mutation Study
GEM

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Medical Conditions
  • EGFR Mutation Positive Non Small Cell Lung Cancer
Primary Contact Details
Benedicte Marchal
+32 2 774 10 78
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01838577
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
  • 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.
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Observational [Patient Registry]
Intervention
Sorry, this information is not available
Intervention Type
See Interventions above
Primary Outcome Measures
    For the second objective, the primary endpoint is Overall survival (OS); 5 years from FPI
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
2000
Participant Inclusion Criteria
    - 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Sutton
Trial Contact(s)
Primary Trial Contact
Benedicte Marchal
+32 2 774 10 78
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Genetics of EGFR Mutation Study (GEM): a Translational Study of the EORTC Lung Group.
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
EORTC-08114
Sponsor(s)
European Organisation for Research and Treatment of Cancer - EORTC
Key Dates

Recruitment Start Date

Sep 2013

Recruitment End Date

Dec 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

19 Apr 2013

Date updated in source

11 Oct 2016