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NCT01081496 Clinical Trial

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)

Non Small Cell Lung Cancer Clinical Trial

— Spanish REASON  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01081496
Other study ID # NIS-OES-DUM-2009/1
Secondary ID
Status Completed
Phase N/A
First received March 1, 2010
Last updated March 15, 2011
Start date March 2010
Est. completion date February 2011

Study information
Verified date March 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date February 2011
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Research Site Albacete
Spain Research Site Alicante
Spain Research Site Barcelona
Spain Research Site Caceres
Spain Research Site Cordoba
Spain Research Site Elche Alicante
Spain Research Site Girona
Spain Research Site Granada
Spain Research Site Jaen
Spain Research Site Lugo
Spain Research Site Madrid
Spain Research Site Malaga
Spain Research Site Murcia
Spain Research Site Oviedo Asturias
Spain Research Site Pamplona Navarra
Spain Research Site Pontevedra
Spain Research Site Reus Tarragona
Spain Research Site Salamanca
Spain Research Site Santander
Spain Research Site Santiago de Compostela A Coruna
Spain Research Site Sevilla
Spain Research Site Valencia
Spain Research Site Vigo Pontevedra
Spain Research Site Zaragoza

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). No
Secondary 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 No
Secondary To describe different EGFR mutation methods used in Spain and testing turn around time associated No
Secondary 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) No
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