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

August 9, 2010 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3513

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • Research Site
      • Bruxelles, Belgium
        • Research Site
      • Genk, Belgium
        • Research Site
      • Herstal, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
  • France
      • 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 St Martin, France
        • Research Site
      • Mont de Marsan Cedex, 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, France
        • Research Site
  • Germany
    • Baden W�rttemberg
      • Heidelberg, Baden W�rttemberg, Germany
        • Research Site
    • Baden-W�rtemberg
      • Ulm, Baden-W�rtemberg, Germany
        • Research Site
    • Baden-W�rttemberg
      • Lowenstein, Baden-W�rttemberg, Germany
        • Research Site
    • Bayern
      • Munchen-Gauting, Bayern, Germany
        • Research Site
    • Hamburg
      • Hamburg-Harburg, Hamburg, Germany
        • Research Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany
        • Research Site
      • Hemer, Nordrhein-Westfalen, Germany
        • Research Site
    • Sachsen
      • Leipzig, Sachsen, Germany
        • Research Site
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany
        • Research Site
    • Schleswig-Holstein
      • Gro�hansdorf, Schleswig-Holstein, Germany
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Ioannina, Greece
        • Research Site
      • Patra, Greece
        • Research Site
      • Piraeus, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
    • Crete
      • Heraklio, Crete, Greece
        • Research Site
  • Italy
      • 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, Italy
        • Research Site
  • Portugal
      • Lisboa, Portugal
        • Research Site
      • Ponta Delgada, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
      • Sta.Ma Feira, Portugal
        • Research Site
      • V.N: de Gaia, Portugal
        • Research Site
  • Spain
      • 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
      • Tenerife, Spain
        • Research Site
      • Tudela, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Xativa, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
    • Tenerife
      • Sta Cruz de Tenerife, Tenerife, Spain
        • Research Site
  • Turkey
      • Adana, Turkey
        • Research Site
      • Ankara, Turkey
        • Research Site
      • Gaziantep, Turkey
        • Research Site
      • Istanbul, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
      • Konya, Turkey
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide accurate, reliable information on NSCLC clinical management across European countries in order to detect unmet medical needs of this disease
Time Frame: 1 year follow up
1 year follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 1 year follow up
1 year follow up
To detect differences in clinical outcomes and related factors among countries.
Time Frame: 1 year follow up
1 year follow up
To identify factors associated with clinical outcomes (patient, disease stage and clinical management related factors): predictive modelling for improved patient outcome.
Time Frame: 1 year follow up
1 year follow up
To identify factors associated with the different levels of functional status and quality of life.
Time Frame: 1 year follow up
1 year follow up
To compare the use of health care resources among countries.
Time Frame: 1 year follow up
1 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Alfredo Carrato, MD, Hospital Ramón y Cajal, Madrid (Spain)
  • Study Director: Esteban Medina, Medical Department, AstraZeneca Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (Estimate)

January 29, 2009

Study Record Updates

Last Update Posted (Estimate)

August 10, 2010

Last Update Submitted That Met QC Criteria

August 9, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OEU-DUM-2008/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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