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

NCT ID: NCT00997230

Last Updated: 2013-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4243 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-10-31

Brief Summary

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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).

Detailed Description

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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)

Conditions

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Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer

Keywords

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EGFR mutation ,newly diagnosed NSCLC, locally advanced or metastatic NSCLC

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Dr. H. Brasch

Role: STUDY_DIRECTOR

AstraZeneca Germany

PD Dr. med. Wolfgang Schutte

Role: PRINCIPAL_INVESTIGATOR

06120 Halle-Dolau, Germany

Locations

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Aachen, , Germany

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Amberg, , Germany

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Ansbach, , Germany

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Aschaffenburg, , Germany

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Augsburg, , Germany

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Bad Berka, , Germany

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Ballenstedt, , Germany

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Bamberg, , Germany

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Bayreuth, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bitterfeld-Wolfen, , Germany

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Bochum, , Germany

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Bonn, , Germany

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Borstel, , Germany

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Bottrop, , Germany

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Braunschweig, , Germany

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Bremen, , Germany

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Bremerhaven, , Germany

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Celle, , Germany

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Chemnitz, , Germany

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Cologne, , Germany

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Coswig, , Germany

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Cottbus, , Germany

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Darmstadt, , Germany

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Deggendorf, , Germany

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Dessau, , Germany

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Donaustauf, , Germany

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Dortmund, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Eisenach, , Germany

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Erlangen, , Germany

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Essen, , Germany

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Esslingen am Neckar, , Germany

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Flensburg, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Freising, , Germany

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Fulda, , Germany

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Gerlingen, , Germany

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Gieben, , Germany

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Goslar, , Germany

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Göttingen, , Germany

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Greifenstein, , Germany

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Grobhansdorf, , Germany

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Halle, , Germany

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Halle-Dolau, , Germany

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Hamburg, , Germany

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Hamm, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Hemer, , Germany

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Hof, , Germany

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Homburg, , Germany

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Immenhausen, , Germany

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Jena, , Germany

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Karlsruhe, , Germany

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Kassel, , Germany

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Kiel, , Germany

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Koblenz, , Germany

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Landshut, , Germany

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Leipzig, , Germany

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Lemgo, , Germany

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Leverkusen, , Germany

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Lostau, , Germany

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Löwenstein, , Germany

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Ludwigshafen, , Germany

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Lübeck, , Germany

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Lüneburg, , Germany

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Lünen, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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Marburg, , Germany

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Minden, , Germany

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Moers, , Germany

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Mülheim, , Germany

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München, , Germany

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Münnerstadt, , Germany

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Münster, , Germany

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Neuss, , Germany

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Nordhausen, , Germany

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Northeim, , Germany

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Nuremberg, , Germany

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Oberhausen, , Germany

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Offenbach, , Germany

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Offenburg, , Germany

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Oldenburg, , Germany

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Osnabrück, , Germany

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Ostfildern, , Germany

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Paderborn, , Germany

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Passau, , Germany

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Querfurt, , Germany

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Recklinghausen, , Germany

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Regensburg, , Germany

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Rosenheim, , Germany

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Rostock, , Germany

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Saarbrücken, , Germany

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Schönebeck, , Germany

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Solingen, , Germany

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Sonneberg, , Germany

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Stralsund, , Germany

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Stuttgart, , Germany

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Suhl, , Germany

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Treuenbrietzen, , Germany

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Trier, , Germany

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Tübingen, , Germany

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Ulm, , Germany

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Velbert, , Germany

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Villingen-Schwenningen, , Germany

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Völklingen, , Germany

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Wangen/Allgau, , Germany

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Weiden, , Germany

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Wiesbaden, , Germany

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Würselen, , Germany

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Würzburg, , Germany

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Zusmarshausen, , Germany

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Countries

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Germany

References

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Schuette W, Schirmacher P, Eberhardt WEE, Dietel M, Zirrgiebel U, Muehlenhoff L, Thomas M. Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study. BMC Cancer. 2018 Feb 5;18(1):135. doi: 10.1186/s12885-018-4032-3.

Reference Type DERIVED
PMID: 29402243 (View on PubMed)

Other Identifiers

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NIS-ODE-DUM-2009/1

Identifier Type: -

Identifier Source: org_study_id