NCT00831909

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,513

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Geographic Reach
8 countries

162 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 10, 2010

Status Verified

August 1, 2010

Enrollment Period

1.5 years

First QC Date

January 28, 2009

Last Update Submit

August 9, 2010

Conditions

Keywords

Lung CancerNSCLC managementNSCLC use of health care resources

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

  • To detect differences in clinical outcomes and related factors among countries.

    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.

    1 year follow up

  • To identify factors associated with the different levels of functional status and quality of life.

    1 year follow up

  • To compare the use of health care resources among countries.

    1 year follow up

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (162)

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Antwerp, Belgium

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Brussels, Belgium

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Genk, Belgium

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Herstal, Belgium

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Liège, Belgium

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Aix-en-Provence, France

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Ambilly, France

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Antibes, France

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Aulnay-sous-Bois, France

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Bar-le-Duc, France

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Beauvais, France

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Beuvry, France

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Bordeaux, France

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Brest, France

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Cahors, France

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Castelnau-le-Lez, France

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Chalon-sur-Saône, France

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Chauny, France

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Chevilly-Larue, France

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Cholet, France

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Clamart, France

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Colmar, France

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Compiègne, France

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Coulommiers, France

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Denain, France

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Dijon, France

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Douai, France

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Draguignan, France

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Épinal, France

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Flers, France

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Givors, France

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Granville, France

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Grasse, France

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Guingamp, France

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Hyères, France

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Jonzac, France

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La Ferté-Bernard, France

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La Rochelle, France

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La Tronche, France

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Le Mans, France

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Liévin, France

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Limoges, France

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Longjumeau, France

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Lyon, France

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Mantes-la-Jolie, France

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Martigues, France

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Meaux, France

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Metz, France

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Metz-Tessy, France

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Mont-de-Marsan, France

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Mont-Saint-Martin, France

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Montpellier, France

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Moulins, France

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Mulhouse, France

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Nancy, France

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Nevers, France

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Nice, France

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Nîmes, France

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Oloron-Sainte-Marie, France

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Paris, France

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Perpignan, France

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Pierre-Bénite, France

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Pontoise, France

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Quimper, France

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Rambouillet, France

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Reims, France

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Rennes, France

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Saint-Aubin-lès-Elbeuf, France

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Saint-Priest-en-Jarez, France

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Saverne, France

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Soissons, France

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Strasbourg, France

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Thonon-les-Bains, France

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Toulon, France

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Toulon Armees, France

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Toulouse, France

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Valence, France

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Vandœuvre-lès-Nancy, France

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Verdun, France

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Vesoul, France

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Vire, France

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Heidelberg, Baden W�rttemberg, Germany

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Ulm, Baden-W�rtemberg, Germany

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Löwenstein, Baden-W�rttemberg, Germany

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Munchen-Gauting, Bavaria, Germany

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Harburg, Hamburg, Germany

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Essen, North Rhine-Westphalia, Germany

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Hemer, North Rhine-Westphalia, Germany

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Leipzig, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Gro�hansdorf, Schleswig-Holstein, Germany

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Athens, Athens, Greece

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Heraklio, Crete, Greece

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Ioannina, Ioannina, Greece

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Pátrai, Patra, Greece

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Piraeus, Piraeus, Greece

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Thessaloniki, Thessaloniki, Greece

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Bologna, Italy

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Brindisi, Italy

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Carpi, Italy

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Cattolica, Italy

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Cesena, Italy

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Cremona, Italy

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Faenza, Italy

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Fano, Italy

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Legnano, Italy

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Lido di Camaiore, Italy

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Lugo, Italy

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Mantova, Italy

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Meldola, Italy

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Milan, Italy

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Napoli, Italy

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Parma, Italy

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Perugia, Italy

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Ravenna, Italy

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Rimini, Italy

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S. Giovanni Rotondo, Italy

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Saronno, Italy

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Sondrio, Italy

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Verona, Italy

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Lisbon, Portugal

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Ponta Delgada, Portugal

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Porto, Portugal

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Sta.Ma Feira, Portugal

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V.N: de Gaia, Portugal

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Madrid, Madrid, Spain

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Santa Cruz de Tenerife, Tenerife, Spain

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A Coruña, Spain

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Alicante, Spain

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Barcelona, Spain

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Cabueñes, Spain

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Calella, Spain

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Castellon, Spain

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Córdoba, Spain

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Cuenca, Spain

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Elche, Spain

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Jaén, Spain

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León, Spain

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Lleida, Spain

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Madrid, Spain

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Manacor, Spain

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Mataró, Spain

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Málaga, Spain

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Melilla, Spain

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Oviedo, Spain

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Palma de Mallorca, Spain

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Pamplona, Spain

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Puerto Real, Spain

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Sagunto, Spain

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Salamanca, Spain

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Santa Cruz de Tenerife, Spain

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Seville, Spain

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Tudela, Spain

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Valencia, Spain

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Xàtiva, Spain

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Zaragoza, Spain

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Gaziantep, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Konya, Turkey (Türkiye)

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Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alfredo Carrato, MD

    Hospital Ramón y Cajal, Madrid (Spain)

    PRINCIPAL INVESTIGATOR
  • Esteban Medina

    Medical Department, AstraZeneca Spain

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 10, 2010

Record last verified: 2010-08

Locations