Clinical trial NCT01260038: Study in NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in Region Antwerp, Belgium.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
observational study
EGFR mutation analysis
EGFR mutation status
testing turn around time
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: AstraZeneca
First posted: 2010-12-15
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: newly diagnosed patients with Non Small Cell Lung Cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: testing turn around time (in days)
timeFrame: up to 1 month
Secondary outcomes:
measure: demographics
timeFrame: baseline
measure: correlation between pulmonary function/pulmonary antecedents and EGFR-mutation status
timeFrame: baseline
measure: correlation between family history with regards to cancer and EGFR-mutation status
timeFrame: baseline
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
state: Antwerpen
city: Antwerpen
country: Belgium
facility: AZ Monica
city: Antwerpen
country: Belgium
facility: GZA Sint Vincentius - Sint Augustinus
city: Antwerpen
country: Belgium
facility: ZNA Middelheim - ZNA STER - ZNA Jan Palfijn
city: Bornem
country: Belgium
facility: AZ St Jozef Bornem en Willebroek
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Geel
country: Belgium
facility: AZ St Dimpna
city: Herentals
country: Belgium
facility: AZ St Elisabeth
city: Mol
country: Belgium
facility: AZ Mol
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Turnhout
country: Belgium
facility: AZ Turnhout
Study officials:
affiliation: UZA + Thoracale Oncologie Groep Antwerpen
name: Paul R Germonpre, MD
role: PRINCIPAL_INVESTIGATOR
References: