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

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:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

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.

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

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

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 May 16, 2013