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)

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01081496

Acronym

Spanish REASON

Enrollment

1000

Registered

2010-03-05

Start date

2010-03-31

Completion date

2011-02-28

Last updated

2011-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—
To describe different EGFR mutation methods used in Spain and testing turn around time associated	—
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)	—

Countries

Spain

Outcome results