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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00831909
First received: January 28, 2009
Last updated: August 9, 2010
Last verified: August 2010
  Purpose

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
NSCLC

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Study to Describe Non-small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Europe. Lung

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To detect differences in clinical outcomes and related factors among countries. [ Time Frame: 1 year follow up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To identify factors associated with the different levels of functional status and quality of life. [ Time Frame: 1 year follow up ] [ Designated as safety issue: No ]
  • To compare the use of health care resources among countries. [ Time Frame: 1 year follow up ] [ Designated as safety issue: No ]

Enrollment: 3513
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by AstraZeneca

Additional 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
Study First Received: January 28, 2009
Last Updated: August 9, 2010
Health Authority: Spain: Ethics Committee
Belgium: Institutional Review Board
France: French Data Protection Authority
Germany: Ethics Commission
Greece: National Organization of Medicines
Italy: Ethics Committee
Portugal: Ethics Committee for Clinical Research
Turkey: Ministry of Health

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014