Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or m

The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).

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Key information

Conditions

Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aachen, Germany

About this study

An NIS Registry for the Epidemiological and Scientific evaluation of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic NSCLC (stage IIIB/IV non-small cell lung cancer)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV). Mixed histology of small cell and non-small cell lung cancer

Treatment and study plan

Primary outcomes

The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation status with clinico-pathological characteristics

Time frame: Days 1-10

Secondary outcomes

To collect real-life clinical outcome data in all EGFR M+ patients up to and including progression.To collect real-life pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients.

Time frame: Study Days 21-30

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An NIS Registry for the Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer (Stage IIIB/IV Non-small Cell Lung Cancer)

Acronym: REASON

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Oct 19, 2009
Registry last updated: Oct 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed