Clinical trial NCT00997230: Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or m
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer
Keywords: EGFR mutation ,newly diagnosed NSCLC, locally advanced or metastatic NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-19
Enrollment: 4243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: clinical setting

Brief summary: 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: 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)

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

Primary outcomes:
measure: 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
timeFrame: Days 1-10
Secondary outcomes:
measure: 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.
timeFrame: Study Days 21-30
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Research Site
city: Amberg
country: Germany
facility: Research Site
city: Ansbach
country: Germany
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bad Berka
country: Germany
facility: Research Site
city: Ballenstedt
country: Germany
facility: Research Site
city: Bamberg
country: Germany
facility: Research Site
city: Bayreuth
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bielefeld
country: Germany
facility: Research Site
city: Bitterfeld-Wolfen
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Borstel
country: Germany
facility: Research Site
city: Bottrop
country: Germany
facility: Research Site
city: Braunschweig
country: Germany
facility: Research Site
city: Bremen
country: Germany
facility: Research Site
city: Bremerhaven
country: Germany
facility: Research Site
city: Celle
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Coswig
country: Germany
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
city: Darmstadt
country: Germany
facility: Research Site
city: Deggendorf
country: Germany
facility: Research Site
city: Dessau-Rosslau
country: Germany
facility: Research Site
city: Donaustauf
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Eisenach
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Esslingen
country: Germany
facility: Research Site
city: Flensburg
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Freising
country: Germany
facility: Research Site
city: Fulda
country: Germany
facility: Research Site
city: Gerlingen
country: Germany
facility: Research Site
city: Gieben
country: Germany
facility: Research Site
city: Goslar
country: Germany
facility: Research Site
city: Gottingen
country: Germany
facility: Research Site
city: Greifenstein
country: Germany
facility: Research Site
city: Grobhansdorf
country: Germany
facility: Research Site
city: Halle-Dolau
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamm
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Hemer
country: Germany
facility: Research Site
city: Hof
country: Germany
facility: Research Site
city: Homburg
country: Germany
facility: Research Site
city: Immenhausen
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Koblenz
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Landshut
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Lemgo
country: Germany
facility: Research Site
city: Leverkusen
country: Germany
facility: Research Site
city: Lostau
country: Germany
facility: Research Site
city: Lowenstein
country: Germany
facility: Research Site
city: Lubeck
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Luneburg
country: Germany
facility: Research Site
city: Lunen
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Minden
country: Germany
facility: Research Site
city: Moers
country: Germany
facility: Research Site
city: Mulheim
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Munnerstadt
country: Germany
facility: Research Site
city: Munster
country: Germany
facility: Research Site
city: Neuss
country: Germany
facility: Research Site
city: Nordhausen
country: Germany
facility: Research Site
city: Northeim
country: Germany
facility: Research Site
city: Nurnberg
country: Germany
facility: Research Site
city: Oberhausen
country: Germany
facility: Research Site
city: Offenbach
country: Germany
facility: Research Site
city: Offenburg
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Osnabruck
country: Germany
facility: Research Site
city: Ostfildern
country: Germany
facility: Research Site
city: Paderborn
country: Germany
facility: Research Site
city: Passau
country: Germany
facility: Research Site
city: Querfurt
country: Germany
facility: Research Site
city: Recklinghausen
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Rosenheim
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Saarbrucken
country: Germany
facility: Research Site
city: Schonebeck
country: Germany
facility: Research Site
city: Solingen
country: Germany
facility: Research Site
city: Sonneberg
country: Germany
facility: Research Site
city: Stralsund
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Suhl
country: Germany
facility: Research Site
city: Treuenbrietzen
country: Germany
facility: Research Site
city: Trier
country: Germany
facility: Research Site
city: Tubingen
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Velbert
country: Germany
facility: Research Site
city: Villingen-Schwenningen
country: Germany
facility: Research Site
city: Volklingen
country: Germany
facility: Research Site
city: Wangen/Allgau
country: Germany
facility: Research Site
city: Weiden
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Wurselen
country: Germany
facility: Research Site
city: Wurzburg
country: Germany
facility: Research Site
city: Zusmarshausen
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca Germany
name: Prof. Dr. H. Brasch
role: STUDY_DIRECTOR
affiliation: 06120 Halle-Dolau, Germany
name: PD Dr. med. Wolfgang Schutte
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.