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


N/A
18 Years
N/A
Not Enrolling
Both
EGFR Mutation Positive Non Small Cell Lung Cancer

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Trial Information

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


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.

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.

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

For the second objective, the primary endpoint is Overall survival (OS)

Outcome Time Frame:

5 years from FPI

Safety Issue:

No

Principal Investigator

Sanjay Popat, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden Hospital, Chelsea, London, UK

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

EORTC-08114

NCT ID:

NCT01838577

Start Date:

September 2013

Completion Date:

Related Keywords:

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

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