Clinical trial NCT01081496: Epidemiological Study to Evaluate the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Official title: Epidemiological Study to Evaluate the Prevalence of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic NSCLC (Stage IIIB/IV Non-small Cell Lung Cancer)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: EGFR mutation, Non-small cell lung carcinoma, Spain
Evaluate the prevalence of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To be recruited by Oncologist

Brief summary: To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV)

Exclusion Criteria:

* Mixed histology of small cell and non-small cell lung cancer

Primary outcomes:
measure: To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).
Secondary outcomes:
measure: Correlate EGFR mutation status with clinico-pathological characteristics. The study will aim to determine the prevalence of EGFR M+ lung cancers in patients with clinico-pathological characteristics not commonly associated with EGFR mutation positivity
measure: To describe different EGFR mutation methods used in Spain and testing turn around time associated
measure: To determine the % of confirmed stage IIIB/IV NSCLC patients who cannot be tested for EGFR mutation and the reasons for not testing (% of EGFR Mnt)
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Research Site
state: A Coruna
city: Elche
country: Spain
facility: Research Site
state: Alicante
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: Reus
country: Spain
facility: Research Site
state: Tarragona
city: Albacete
country: Spain
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Caceres
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Girona
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
affiliation: Medical Department. Mediclin-AstraZeneca. Spain
name: Carmen Gonzalez Arenas
role: STUDY_DIRECTOR
References:
citation: Esteban E, Majem M, Martinez Aguillo M, Martinez Banaclocha N, Domine M, Gomez Aldaravi L, Juan O, Cajal R, Gonzalez Arenas MC, Provencio M. Prevalence of EGFR mutations in newly diagnosed locally advanced or metastatic non-small cell lung cancer Spanish patients and its association with histological subtypes and clinical features: The Spanish REASON study. Cancer Epidemiol. 2015 Jun;39(3):291-7. doi: 10.1016/j.canep.2015.02.003. Epub 2015 Mar 9.