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

Completed

• Conditions: NSCLC

• Registration Number: NCT00831909
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-09
• Last Update Posted: 2010-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3513

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Research Site; 🇹🇷 Konya, Turkey