Clinical trial NCT00831909: Epidemiological Study to Describe NSCLC Clinical Management Patterns in Europe. Lung-EPICLIN
Official title: Epidemiological Study to Describe Non-small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Europe. Lung
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSCLC
Keywords: Lung Cancer
NSCLC management
NSCLC use of health care resources
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-29
Enrollment: 3513
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: All NSCLC patients attending the responsible department of treating this type of patients (e.g. Oncology Department, Pneumology Department) for the first time (regardless of whether the patient is diagnosed with locally, advanced or metastatic disease) at the participating sites from the first of January 2009 to the end of March 2009. Patients diagnosed, or even treated, in other departments within the same hospital or in another hospital are susceptible to be included in the study if full access to the patient's medical record is made available.

Brief summary: To provide accurate and reliable information regarding NSCLC clinical management across European countries in order to detect unmet medical needs of this disease in terms of: patient and hospital characteristics; diagnostic and treatment approaches: initial and subsequent, follow-up patterns in clinical management; outcomes: symptoms, death, functionality, quality of life; use of resources and burden on patients and health care systems.


Eligibility criteria: Inclusion Criteria:

* Confirmed NSCLC diagnosis (e.g. bronchoscope or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between January 1st, 2009 and March 31st, 2009.
* For PRO sub-sample: ability to read and write since they will be asked to participate in the PRO part of the study. Selection will not be based on the disease stage of each patient, in order to avoid a selection bias.

Exclusion Criteria:

* According to the study design there will not be any exclusion criteria in order to provide a high external validity and to obtain the most accurate real daily practice information.

Primary outcomes:
measure: To provide accurate, reliable information on NSCLC clinical management across European countries in order to detect unmet medical needs of this disease
timeFrame: 1 year follow up
Secondary outcomes:
measure: To assess the differences in patient characteristics, disease stage (differentiating between non-advanced disease, locally advanced disease, metastatic disease), and in clinical management across European countries.
timeFrame: 1 year follow up
measure: To detect differences in clinical outcomes and related factors among countries.
timeFrame: 1 year follow up
measure: To identify factors associated with clinical outcomes (patient, disease stage and clinical management related factors): predictive modelling for improved patient outcome.
timeFrame: 1 year follow up
measure: To identify factors associated with the different levels of functional status and quality of life.
timeFrame: 1 year follow up
measure: To compare the use of health care resources among countries.
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Herstal
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Aix En Provence Cedex 1
country: France
facility: Research Site
city: Ambilly
country: France
facility: Research Site
city: Antibes Cedex
country: France
facility: Research Site
city: Aulnay Sous Bois Cedex
country: France
facility: Research Site
city: Bar Le Duc Cedex
country: France
facility: Research Site
city: Beauvais Cedex
country: France
facility: Research Site
city: Beuvry
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Brest Cedex 2
country: France
facility: Research Site
city: Cahors Cedex 9
country: France
facility: Research Site
city: Castelnau Le Lez
country: France
facility: Research Site
city: Chalon Sur Saone
country: France
facility: Research Site
city: Chauny Cedex
country: France
facility: Research Site
city: Chevilly Larue Cedex
country: France
facility: Research Site
city: Cholet Cedex
country: France
facility: Research Site
city: Clamart Cedex
country: France
facility: Research Site
city: Colmar Cedex
country: France
facility: Research Site
city: Compiegne Cedex
country: France
facility: Research Site
city: Coulommiers Cedex
country: France
facility: Research Site
city: Denain Cedex
country: France
facility: Research Site
city: Dijon Cedex
country: France
facility: Research Site
city: Douai Cedex
country: France
facility: Research Site
city: Draguignan Cedex
country: France
facility: Research Site
city: Epinal Cedex
country: France
facility: Research Site
city: Flers Cedex
country: France
facility: Research Site
city: Givors Cedex
country: France
facility: Research Site
city: Granville Cedex
country: France
facility: Research Site
city: Grasse Cedex
country: France
facility: Research Site
city: Guingamp Cedex
country: France
facility: Research Site
city: Hyeres
country: France
facility: Research Site
city: Jonzac Cedex
country: France
facility: Research Site
city: La Ferte Bernard Cedex
country: France
facility: Research Site
city: La Rochelle Cedex 1
country: France
facility: Research Site
city: La Tronche
country: France
facility: Research Site
city: Le Mans Cedex 9
country: France
facility: Research Site
city: Lievin Cedex
country: France
facility: Research Site
city: Limoges Cedex 1
country: France
facility: Research Site
city: Longjumeau Cedex
country: France
facility: Research Site
city: Lyon Cedex 04
country: France
facility: Research Site
city: Lyon Cedex 08
country: France
facility: Research Site
city: Mantes La Jolie Cedex
country: France
facility: Research Site
city: Martigues Cedex
country: France
facility: Research Site
city: Meaux Cedex
country: France
facility: Research Site
city: Metz Cedex 01
country: France
facility: Research Site
city: Metz Cedex 03
country: France
facility: Research Site
city: Metz Tessy
country: France
facility: Research Site
city: Mont de Marsan Cedex
country: France
facility: Research Site
city: Mont St Martin
country: France
facility: Research Site
city: Montpellier Cedex 5
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Moulins Cedex
country: France
facility: Research Site
city: Mulhouse Cedex 1
country: France
facility: Research Site
city: Mulhouse Cedex
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Nevers Cedex
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Nimes Cedex 9
country: France
facility: Research Site
city: Oloron Ste Marie Cedex
country: France
facility: Research Site
city: Paris Cedex 04
country: France
facility: Research Site
city: Paris Cedex 05
country: France
facility: Research Site
city: Paris Cedex 12
country: France
facility: Research Site
city: Paris Cedex 15
country: France
facility: Research Site
city: Perpignan Cedex
country: France
facility: Research Site
city: Pierre Benite Cedex
country: France
facility: Research Site
city: Pontoise
country: France
facility: Research Site
city: Quimper Cedex
country: France
facility: Research Site
city: Rambouillet Cedex
country: France
facility: Research Site
city: Reims Cedex
country: France
facility: Research Site
city: Rennes Cedex
country: France
facility: Research Site
city: Saverne Cedex
country: France
facility: Research Site
city: Soissons Cedex
country: France
facility: Research Site
city: St Aubin Les Elbeuf
country: France
facility: Research Site
city: St Priest En Jarez Cedex
country: France
facility: Research Site
city: Strasbourg Cedex
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Thonon Les Bains Cedex
country: France
facility: Research Site
city: Toulon Armees
country: France
facility: Research Site
city: Toulon Cedex
country: France
facility: Research Site
city: Toulouse Cedex 3
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
facility: Research Site
city: Valence Cedex 9
country: France
facility: Research Site
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Research Site
city: Verdun Cedex
country: France
facility: Research Site
city: Vesoul Cedex
country: France
facility: Research Site
city: Vire Cedex
country: France
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
state: Baden W�rttemberg
city: Ulm
country: Germany
facility: Research Site
state: Baden-W�rtemberg
city: Lowenstein
country: Germany
facility: Research Site
state: Baden-W�rttemberg
city: Munchen-Gauting
country: Germany
facility: Research Site
state: Bayern
city: Hamburg-Harburg
country: Germany
facility: Research Site
state: Hamburg
city: Essen
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Hemer
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: Research Site
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Research Site
state: Sachsen
city: Gro�hansdorf
country: Germany
facility: Research Site
state: Schleswig-Holstein
city: Heraklio
country: Greece
facility: Research Site
state: Crete
city: Athens
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Piraeus
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Brindisi
country: Italy
facility: Research Site
city: Carpi
country: Italy
facility: Research Site
city: Cattolica
country: Italy
facility: Research Site
city: Cesena
country: Italy
facility: Research Site
city: Cremona
country: Italy
facility: Research Site
city: Faenza
country: Italy
facility: Research Site
city: Fano
country: Italy
facility: Research Site
city: Legnano
country: Italy
facility: Research Site
city: Lido di Camaiore
country: Italy
facility: Research Site
city: Lugo
country: Italy
facility: Research Site
city: Mantova
country: Italy
facility: Research Site
city: Meldola
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Ravenna
country: Italy
facility: Research Site
city: Rimini
country: Italy
facility: Research Site
city: S. Giovanni Rotondo
country: Italy
facility: Research Site
city: Saronno
country: Italy
facility: Research Site
city: Sondrio
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Ponta Delgada
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Sta.Ma Feira
country: Portugal
facility: Research Site
city: V.N: de Gaia
country: Portugal
facility: Research Site
city: Sta Cruz de Tenerife
country: Spain
facility: Research Site
state: Tenerife
city: A Coruna
country: Spain
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cabuenes
country: Spain
facility: Research Site
city: Calella
country: Spain
facility: Research Site
city: Castellon
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Cuenca
country: Spain
facility: Research Site
city: Elche
country: Spain
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
city: Leon
country: Spain
facility: Research Site
city: Lerida
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Manacor
country: Spain
facility: Research Site
city: Mataro
country: Spain
facility: Research Site
city: Melilla
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Puerto Real
country: Spain
facility: Research Site
city: Sagunto
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Tenerife
country: Spain
facility: Research Site
city: Tudela
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Xativa
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Gaziantep
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Konya
country: Turkey
facility: Research Site
Study officials:
affiliation: Hospital Ramón y Cajal, Madrid (Spain)
name: Alfredo Carrato, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Department, AstraZeneca Spain
name: Esteban Medina
role: STUDY_DIRECTOR
References:
citation: Vergnenegre A, Carrato A, Thomas M, Jernigan C, Medina J, Cruciani G. Real-world healthcare resource utilization in a European non-small cell lung cancer population: the EPICLIN-Lung study. Curr Med Res Opin. 2014 Mar;30(3):463-70. doi: 10.1185/03007995.2013.860373. Epub 2013 Nov 18.
citation: Carrato A, Vergnenegre A, Thomas M, McBride K, Medina J, Cruciani G. Clinical management patterns and treatment outcomes in patients with non-small cell lung cancer (NSCLC) across Europe: EPICLIN-Lung study. Curr Med Res Opin. 2014 Mar;30(3):447-61. doi: 10.1185/03007995.2013.860372. Epub 2013 Nov 18.