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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00831909
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : August 10, 2010
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease
NSCLC

Study Type : Observational
Actual Enrollment : 3513 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Study to Describe Non-small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Europe. Lung
Study Start Date : January 2009
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To detect differences in clinical outcomes and related factors among countries. [ Time Frame: 1 year follow up ]
  3. 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 ]
  4. To identify factors associated with the different levels of functional status and quality of life. [ Time Frame: 1 year follow up ]
  5. To compare the use of health care resources among countries. [ Time Frame: 1 year follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831909


  Show 170 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Alfredo Carrato, MD Hospital Ramón y Cajal, Madrid (Spain)
Study Director: Esteban Medina Medical Department, AstraZeneca Spain

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nadia Badri, European Medical Affairs Director Oncology, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00831909     History of Changes
Other Study ID Numbers: NIS-OEU-DUM-2008/1
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: August 10, 2010
Last Verified: August 2010

Keywords provided by AstraZeneca:
Lung Cancer
NSCLC management
NSCLC use of health care resources