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) (Spanish REASON)

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01081496

First received: March 1, 2010

Last updated: March 15, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 1, 2010

Last Updated Date

March 15, 2011

Start Date ^ICMJE

March 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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). [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01081496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 [ Designated as safety issue: No ]
To describe different EGFR mutation methods used in Spain and testing turn around time associated [ Designated as safety issue: No ]
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) [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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)

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

To be recruited by Oncologist

Condition ^ICMJE

Non Small Cell Lung Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1000

Completion Date

February 2011

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01081496

Other Study ID Numbers ^ICMJE

NIS-OES-DUM-2009/1

Has Data Monitoring Committee

Responsible Party

MC MD, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Carmen Gonzalez Arenas

Medical Department. Mediclin-AstraZeneca. Spain

Information Provided By

AstraZeneca

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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