Epidemiological Study to Describe NSCLC Clinical Management Patterns in Europe. Lung-EPICLIN

NSCLC Clinical Trial

— EPICLIN  

Official title:

Epidemiological Study to Describe Non-small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Europe. Lung

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831909
• Other study ID #: NIS-OEU-DUM-2008/1
• Status: Completed
• Phase: N/A
• First received: January 28, 2009
• Last updated: August 9, 2010
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeBelgium: Institutional Review BoardFrance: French Data Protection AuthorityGermany: Ethics CommissionGreece: National Organization of MedicinesItaly: Ethics CommitteePortugal: Ethics Committee for Clinical ResearchTurkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3513
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Locations

Country	Name	City	State
Belgium	Research Site	Antwerpen
Belgium	Research Site	Bruxelles
Belgium	Research Site	Genk
Belgium	Research Site	Herstal
Belgium	Research Site	Liege
France	Research Site	Aix En Provence Cedex 1
France	Research Site	Ambilly
France	Research Site	Antibes Cedex
France	Research Site	Aulnay Sous Bois Cedex
France	Research Site	Bar Le Duc Cedex
France	Research Site	Beauvais Cedex
France	Research Site	Beuvry
France	Research Site	Bordeaux
France	Research Site	Brest Cedex 2
France	Research Site	Cahors Cedex 9
France	Research Site	Castelnau Le Lez
France	Research Site	Chalon Sur Saone
France	Research Site	Chauny Cedex
France	Research Site	Chevilly Larue Cedex
France	Research Site	Cholet Cedex
France	Research Site	Clamart Cedex
France	Research Site	Colmar Cedex
France	Research Site	Compiegne Cedex
France	Research Site	Coulommiers Cedex
France	Research Site	Denain Cedex
France	Research Site	Dijon Cedex
France	Research Site	Douai Cedex
France	Research Site	Draguignan Cedex
France	Research Site	Epinal Cedex
France	Research Site	Flers Cedex
France	Research Site	Givors Cedex
France	Research Site	Granville Cedex
France	Research Site	Grasse Cedex
France	Research Site	Guingamp Cedex
France	Research Site	Hyeres
France	Research Site	Jonzac Cedex
France	Research Site	La Ferte Bernard Cedex
France	Research Site	La Rochelle Cedex 1
France	Research Site	La Tronche
France	Research Site	Le Mans Cedex 9
France	Research Site	Lievin Cedex
France	Research Site	Limoges Cedex 1
France	Research Site	Longjumeau Cedex
France	Research Site	Lyon Cedex 04
France	Research Site	Lyon Cedex 08
France	Research Site	Mantes La Jolie Cedex
France	Research Site	Martigues Cedex
France	Research Site	Meaux Cedex
France	Research Site	Metz Cedex 01
France	Research Site	Metz Cedex 03
France	Research Site	Metz Tessy
France	Research Site	Mont de Marsan Cedex
France	Research Site	Mont St Martin
France	Research Site	Montpellier
France	Research Site	Montpellier Cedex 5
France	Research Site	Moulins Cedex
France	Research Site	Mulhouse Cedex
France	Research Site	Mulhouse Cedex 1
France	Research Site	Nancy
France	Research Site	Nevers Cedex
France	Research Site	Nice
France	Research Site	Nimes Cedex 9
France	Research Site	Oloron Ste Marie Cedex
France	Research Site	Paris Cedex 04
France	Research Site	Paris Cedex 05
France	Research Site	Paris Cedex 12
France	Research Site	Paris Cedex 15
France	Research Site	Perpignan Cedex
France	Research Site	Pierre Benite Cedex
France	Research Site	Pontoise
France	Research Site	Quimper Cedex
France	Research Site	Rambouillet Cedex
France	Research Site	Reims Cedex
France	Research Site	Rennes Cedex
France	Research Site	Saverne Cedex
France	Research Site	Soissons Cedex
France	Research Site	St Aubin Les Elbeuf
France	Research Site	St Priest En Jarez Cedex
France	Research Site	Strasbourg
France	Research Site	Strasbourg Cedex
France	Research Site	Thonon Les Bains Cedex
France	Research Site	Toulon Armees
France	Research Site	Toulon Cedex
France	Research Site	Toulouse Cedex 3
France	Research Site	Toulouse Cedex 9
France	Research Site	Valence Cedex 9
France	Research Site	Vandoeuvre Les Nancy Cedex
France	Research Site	Verdun Cedex
France	Research Site	Vesoul Cedex
France	Research Site	Vire Cedex
Germany	Research Site	Essen	Nordrhein-Westfalen
Germany	Research Site	Gro?hansdorf	Schleswig-Holstein
Germany	Research Site	Halle	Sachsen-Anhalt
Germany	Research Site	Hamburg-Harburg	Hamburg
Germany	Research Site	Heidelberg	Baden W?rttemberg
Germany	Research Site	Hemer	Nordrhein-Westfalen
Germany	Research Site	Leipzig	Sachsen
Germany	Research Site	Lowenstein	Baden-W?rttemberg
Germany	Research Site	Munchen-Gauting	Bayern
Germany	Research Site	Ulm	Baden-W?rtemberg
Greece	Research Site	Athens
Greece	Research Site	Heraklio	Crete
Greece	Research Site	Ioannina
Greece	Research Site	Patra
Greece	Research Site	Piraeus
Greece	Research Site	Thessaloniki
Italy	Research Site	Bologna
Italy	Research Site	Brindisi
Italy	Research Site	Carpi
Italy	Research Site	Cattolica
Italy	Research Site	Cesena
Italy	Research Site	Cremona
Italy	Research Site	Faenza
Italy	Research Site	Fano
Italy	Research Site	Legnano
Italy	Research Site	Lido di Camaiore
Italy	Research Site	Lugo
Italy	Research Site	Mantova
Italy	Research Site	Meldola
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Parma
Italy	Research Site	Perugia
Italy	Research Site	Ravenna
Italy	Research Site	Rimini
Italy	Research Site	S. Giovanni Rotondo
Italy	Research Site	Saronno
Italy	Research Site	Sondrio
Italy	Research Site	Verona
Portugal	Research Site	Lisboa
Portugal	Research Site	Ponta Delgada
Portugal	Research Site	Porto
Portugal	Research Site	Sta.Ma Feira
Portugal	Research Site	V.N: de Gaia
Spain	Research Site	A Coruna
Spain	Research Site	Alicante
Spain	Research Site	Barcelona
Spain	Research Site	Cabuenes
Spain	Research Site	Calella
Spain	Research Site	Castellon
Spain	Research Site	Cordoba
Spain	Research Site	Cuenca
Spain	Research Site	Elche
Spain	Research Site	Jaen
Spain	Research Site	Leon
Spain	Research Site	Lerida
Spain	Research Site	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Manacor
Spain	Research Site	Mataro
Spain	Research Site	Melilla
Spain	Research Site	Oviedo
Spain	Research Site	Palma de Mallorca
Spain	Research Site	Pamplona
Spain	Research Site	Puerto Real
Spain	Research Site	Sagunto
Spain	Research Site	Salamanca
Spain	Research Site	Sevilla
Spain	Research Site	Sta Cruz de Tenerife	Tenerife
Spain	Research Site	Tenerife
Spain	Research Site	Tudela
Spain	Research Site	Valencia
Spain	Research Site	Xativa
Spain	Research Site	Zaragoza
Turkey	Research Site	Adana
Turkey	Research Site	Ankara
Turkey	Research Site	Gaziantep
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Konya

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Greece,  Italy,  Portugal,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide accurate, reliable information on NSCLC clinical management across European countries in order to detect unmet medical needs of this disease		1 year follow up	No
Secondary	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.		1 year follow up	No
Secondary	To detect differences in clinical outcomes and related factors among countries.		1 year follow up	No
Secondary	To identify factors associated with clinical outcomes (patient, disease stage and clinical management related factors): predictive modelling for improved patient outcome.		1 year follow up	No
Secondary	To identify factors associated with the different levels of functional status and quality of life.		1 year follow up	No
Secondary	To compare the use of health care resources among countries.		1 year follow up	No