Study in NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in Region Antwerp, Belgium. (HERMES)
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).
Non Small Cell Lung Cancer
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Personalized 1st-line Treatment of Patients With NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in a Routine Practice Setting in Antwerp.|
- testing turn around time (in days) [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]how long does it take to get the mutation analysis result
- demographics [ Time Frame: baseline ] [ Designated as safety issue: No ]age, gender, tumor histology, smoking history
- correlation between pulmonary function/pulmonary antecedents and EGFR-mutation status [ Time Frame: baseline ] [ Designated as safety issue: No ]
- correlation between family history with regards to cancer and EGFR-mutation status [ Time Frame: baseline ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
At diagnosis a tumor sample is collected for histological evaluation, this sample will be used for the biomarker analysis.
|Study Start Date:||November 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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.
|Universitair Ziekenhuis Antwerpen|
|Edegem, Antwerpen, Belgium, 2650|
|ZNA Middelheim - ZNA STER - ZNA Jan Palfijn|
|GZA Sint Vincentius - Sint Augustinus|
|AZ St Jozef Bornem en Willebroek|
|AZ St Dimpna|
|AZ St Elisabeth|
|Principal Investigator:||Paul R Germonpre, MD||UZA + Thoracale Oncologie Groep Antwerpen|