Study in NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in Region Antwerp, Belgium.

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT01260038
• Lead Sponsor: University Hospital, Antwerp

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-17
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
testing turn around time (in days)	up to 1 month	how long does it take to get the mutation analysis result

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

GZA Sint Vincentius - Sint Augustinus; 🇧🇪 Antwerpen, Belgium

AZ Klina; 🇧🇪 Brasschaat, Belgium

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium

ZNA Middelheim - ZNA STER - ZNA Jan Palfijn; 🇧🇪 Antwerpen, Belgium

AZ St Elisabeth; 🇧🇪 Herentals, Belgium

AZ Turnhout; 🇧🇪 Turnhout, Belgium

AZ Monica; 🇧🇪 Antwerpen, Belgium

AZ St Dimpna; 🇧🇪 Geel, Belgium

AZ Mol; 🇧🇪 Mol, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Antwerpen, Belgium

AZ St Jozef Bornem en Willebroek; 🇧🇪 Bornem, Belgium