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

October 25, 2013 updated by: AstraZeneca

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)

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).

Study Overview

Status

Completed

Conditions

Detailed Description

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)

Study Type

Observational

Enrollment (Actual)

4243

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • Research Site
      • Amberg, Germany
        • Research Site
      • Ansbach, Germany
        • Research Site
      • Aschaffenburg, Germany
        • Research Site
      • Augsburg, Germany
        • Research Site
      • Bad Berka, Germany
        • Research Site
      • Ballenstedt, Germany
        • Research Site
      • Bamberg, Germany
        • Research Site
      • Bayreuth, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bielefeld, Germany
        • Research Site
      • Bitterfeld-Wolfen, Germany
        • Research Site
      • Bochum, Germany
        • Research Site
      • Bonn, Germany
        • Research Site
      • Borstel, Germany
        • Research Site
      • Bottrop, Germany
        • Research Site
      • Braunschweig, Germany
        • Research Site
      • Bremen, Germany
        • Research Site
      • Bremerhaven, Germany
        • Research Site
      • Celle, Germany
        • Research Site
      • Chemnitz, Germany
        • Research Site
      • Coswig, Germany
        • Research Site
      • Cottbus, Germany
        • Research Site
      • Darmstadt, Germany
        • Research Site
      • Deggendorf, Germany
        • Research Site
      • Dessau-Rosslau, Germany
        • Research Site
      • Donaustauf, Germany
        • Research Site
      • Dortmund, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Dusseldorf, Germany
        • Research Site
      • Eisenach, Germany
        • Research Site
      • Erlangen, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Esslingen, Germany
        • Research Site
      • Flensburg, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Freising, Germany
        • Research Site
      • Fulda, Germany
        • Research Site
      • Gerlingen, Germany
        • Research Site
      • Gieben, Germany
        • Research Site
      • Goslar, Germany
        • Research Site
      • Gottingen, Germany
        • Research Site
      • Greifenstein, Germany
        • Research Site
      • Grobhansdorf, Germany
        • Research Site
      • Halle, Germany
        • Research Site
      • Halle-Dolau, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hamm, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Hemer, Germany
        • Research Site
      • Hof, Germany
        • Research Site
      • Homburg, Germany
        • Research Site
      • Immenhausen, Germany
        • Research Site
      • Jena, Germany
        • Research Site
      • Karlsruhe, Germany
        • Research Site
      • Kassel, Germany
        • Research Site
      • Kiel, Germany
        • Research Site
      • Koblenz, Germany
        • Research Site
      • Koln, Germany
        • Research Site
      • Landshut, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Lemgo, Germany
        • Research Site
      • Leverkusen, Germany
        • Research Site
      • Lostau, Germany
        • Research Site
      • Lowenstein, Germany
        • Research Site
      • Lubeck, Germany
        • Research Site
      • Ludwigshafen, Germany
        • Research Site
      • Luneburg, Germany
        • Research Site
      • Lunen, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • Marburg, Germany
        • Research Site
      • Minden, Germany
        • Research Site
      • Moers, Germany
        • Research Site
      • Mulheim, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Munnerstadt, Germany
        • Research Site
      • Munster, Germany
        • Research Site
      • Neuss, Germany
        • Research Site
      • Nordhausen, Germany
        • Research Site
      • Northeim, Germany
        • Research Site
      • Nurnberg, Germany
        • Research Site
      • Oberhausen, Germany
        • Research Site
      • Offenbach, Germany
        • Research Site
      • Offenburg, Germany
        • Research Site
      • Oldenburg, Germany
        • Research Site
      • Osnabruck, Germany
        • Research Site
      • Ostfildern, Germany
        • Research Site
      • Paderborn, Germany
        • Research Site
      • Passau, Germany
        • Research Site
      • Querfurt, Germany
        • Research Site
      • Recklinghausen, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
      • Rosenheim, Germany
        • Research Site
      • Rostock, Germany
        • Research Site
      • Saarbrucken, Germany
        • Research Site
      • Schonebeck, Germany
        • Research Site
      • Solingen, Germany
        • Research Site
      • Sonneberg, Germany
        • Research Site
      • Stralsund, Germany
        • Research Site
      • Stuttgart, Germany
        • Research Site
      • Suhl, Germany
        • Research Site
      • Treuenbrietzen, Germany
        • Research Site
      • Trier, Germany
        • Research Site
      • Tubingen, Germany
        • Research Site
      • Ulm, Germany
        • Research Site
      • Velbert, Germany
        • Research Site
      • Villingen-Schwenningen, Germany
        • Research Site
      • Volklingen, Germany
        • Research Site
      • Wangen/Allgau, Germany
        • Research Site
      • Weiden, Germany
        • Research Site
      • Wiesbaden, Germany
        • Research Site
      • Wurselen, Germany
        • Research Site
      • Wurzburg, Germany
        • Research Site
      • Zusmarshausen, Germany
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

clinical setting

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Days 1-10

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Study Days 21-30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Prof. Dr. H. Brasch, AstraZeneca Germany
  • Principal Investigator: PD Dr. med. Wolfgang Schutte, 06120 Halle-Dolau, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 16, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2013

Last Update Submitted That Met QC Criteria

October 25, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-ODE-DUM-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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