Non Small Cell Lung Cancer
Conditions
Keywords
Non Small Cell Lung Cancer, observational study, EGFR mutation analysis, EGFR mutation status, testing turn around time
Brief summary
This is an observational study to evaluate the feasibility of the implementation of a personalized treatment strategy based on specific tumor marker (f.i. EGFR-mutation) in the routine clinical care setting in the Antwerp region (Belgium).
Detailed description
The favourable results of a number of phase III-trials with gefitinib in NSCLC patients with activating EGFR-mutations, have resulted in the licensing of gefitinib in this indication. This offers the prospect of a true personalized treatment of patients with NSCLC. Implementation of such a personalized treatment strategy is dependent both on the availability of adequate tumor samples for the EGFR-mutation analysis and on the timely reporting of the mutation analysis results. Ideally the results should be available in all patients within 2 weeks of the analysis request.
Interventions
None listed
Sponsors
Universiteit Antwerpen
AstraZeneca
University Hospital, Antwerp
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 years or above * newly diagnosed NSCLC * written informed consent * tumor sample available
Exclusion criteria
* mixed histology of small cell and NSCLC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| testing turn around time (in days) | up to 1 month | how long does it take to get the mutation analysis result |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| demographics | baseline | age, gender, tumor histology, smoking history |
| correlation between pulmonary function/pulmonary antecedents and EGFR-mutation status | baseline | — |
| correlation between family history with regards to cancer and EGFR-mutation status | baseline | — |
Countries
Belgium
Outcome results
None listed