Clinical trial NCT01167972: Observational Study on the Management of Patients With Non Small Cell Lung Cancer Adenocarcinoma
Official title: Observational Study on the Management of Patients With Non Small Cell Lung Cancer (NSCLC) Adenocarcinoma Tested for the Activating Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase (EGFR TK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: M + mutation
Non Small Cell Lung Cancer adenocarcinoma
To determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with NSCLC adenocarcinoma confirmed by histologyPatient for whom a search for the mutational status of EGFR (EGFR-M +, M- or Mx) has been done or is being analyzed

Brief summary: The main objective of the study is to determine the proportion of patients with M + mutation status among patients with Non Small Cell Lung Cancer adenocarcinoma.

Detailed description: MSD

Eligibility criteria: Inclusion Criteria:

* Patient with lung cancer (Non Small Cell Lung Cancer adenocarcinoma)
* Patient for whom a search for the mutational status of EGFR (EGFR-M +, M- or Mx) has been done or is being analyzed

Exclusion Criteria:

* Assessment of mutational status of EGFR is not done

Primary outcomes:
measure: The main objective of the study is to determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma
timeFrame: At baseline
Secondary outcomes:
measure: Describe the therapeutic management according to the mutational status (EGFR M +, EGFR M- and Mx).
timeFrame: 12 months / At each visit
measure: Describe the therapeutic management of patients with EGFR M +.
timeFrame: 12 months / At each visit
measure: Describe the clinical course of patients EGFR-M +, treated for first-line treatment, and then 2nd line treatment, until 31-AUG-2012
timeFrame: 12 months / At each visit
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Research Site
city: Aix En Provence
country: France
facility: Research Site
city: Amilly
country: France
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Antibes
country: France
facility: Research Site
city: Arras
country: France
facility: Research Site
city: Aulnay Sous Bois
country: France
facility: Research Site
city: Auxerre
country: France
facility: Research Site
city: Bastia
country: France
facility: Research Site
city: Bayonne
country: France
facility: Research Site
city: Bethune
country: France
facility: Research Site
city: Blois
country: France
facility: Research Site
city: Bobigny
country: France
facility: Research Site
city: Bois Guillaume
country: France
facility: Research Site
city: Bonneville
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Boulogne Sur Mer
country: France
facility: Research Site
city: Bourg En Bresse
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Brive La Gaillarde
country: France
facility: Research Site
city: Bron
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Chalon Sur Saone
country: France
facility: Research Site
city: Chauny
country: France
facility: Research Site
city: Clermont Ferrand
country: France
facility: Research Site
city: Colmar
country: France
facility: Research Site
city: Compiegne
country: France
facility: Research Site
city: Creil
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Douai
country: France
facility: Research Site
city: Draguignan
country: France
facility: Research Site
city: Fougeres
country: France
facility: Research Site
city: GAP
country: France
facility: Research Site
city: Granville
country: France
facility: Research Site
city: La Roche Sur Yon
country: France
facility: Research Site
city: La Rochelle
country: France
facility: Research Site
city: La Seyne Sur Mer
country: France
facility: Research Site
city: La Source
country: France
facility: Research Site
city: La Tronche
country: France
facility: Research Site
city: Le Plessis Robinson
country: France
facility: Research Site
city: Lens
country: France
facility: Research Site
city: Levallois Perret
country: France
facility: Research Site
city: Libourne
country: France
facility: Research Site
city: Lievin
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Longjumeau
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Mantes La Jolie
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Meaux
country: France
facility: Research Site
city: Mont de Marsan
country: France
facility: Research Site
city: Mont St Martin
country: France
facility: Research Site
city: Montauban
country: France
facility: Research Site
city: Montivilliers
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Moulins
country: France
facility: Research Site
city: Nevers
country: France
facility: Research Site
city: Nimes
country: France
facility: Research Site
city: Niort
country: France
facility: Research Site
city: Oloron Ste Marie
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: PAU
country: France
facility: Research Site
city: Pessac
country: France
facility: Research Site
city: Pierre Benite
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Pontivy
country: France
facility: Research Site
city: Pontoise
country: France
facility: Research Site
city: Pringy
country: France
facility: Research Site
city: Privas
country: France
facility: Research Site
city: Redon
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Roanne
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Saintes
country: France
facility: Research Site
city: Salouel
country: France
facility: Research Site
city: Sarrebourg
country: France
facility: Research Site
city: Soissons
country: France
facility: Research Site
city: St Aubin Les Elbeuf
country: France
facility: Research Site
city: St Brieuc
country: France
facility: Research Site
city: St Denis
country: France
facility: Research Site
city: St Herblain
country: France
facility: Research Site
city: St Pierre
country: France
facility: Research Site
city: St Priest En Jarez
country: France
facility: Research Site
city: St Quentin
country: France
facility: Research Site
city: Ste Clotilde
country: France
facility: Research Site
city: Ste Feyre
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Toulon
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Tourcoing
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Trappes
country: France
facility: Research Site
city: Valence
country: France
facility: Research Site
city: Vendome
country: France
facility: Research Site
city: Verdun
country: France
facility: Research Site
city: Villejuif
country: France
facility: Research Site
city: Villenave D Ornon
country: France
facility: Research Site
city: Yerres
country: France
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Corrine Bernaud, Medical Director
role: STUDY_DIRECTOR
References: