Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN)

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT01069835
• Lead Sponsor: AstraZeneca

Brief Summary

The overall aim of the study is:

To provide accurate and reliable information regarding NSCLC clinical management across Central Eastern European countries and Russia 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. Addendum objective is to collect epidemiological data on EGFR mutation status (M+, M-) in the Russian population

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-15
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2011-03
• Study Completion: 2012-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

• Confirmed NSCLC diagnosis (e.g.bronchoscopic biopsy or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between January 1st, 2010 and March 31st, 2010
• For Patient Reported Outcome (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.
• Tumour tissue samples (in paraffin-embedded blocks) suitable for EGFR mutation testing available.

Exclusion Criteria

• Mixed histology of small cell and non-small cell lung cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the differences in patient characteristics, disease stage (differentiating between non-advanced disease, locally advanced disease, metastatic disease), and in clinical management across Central Eastern European countries and Russia	24 months

Secondary Outcome Measures

Name	Time	Method
To detect differences in clinical outcomes and related factors among countries	24 months
To compare the use of health care resources among countries	24 months
To identify factors associated with clinical outcomes (patient, disease stage -see above- and clinical management related factors): predictive modelling for improved patient outcome	24 months
To identify factors associated with the different levels of functional status and quality of life	24 months

Trial Locations

Locations (1)

Research Site; 🇷🇺 Zhukovsky, Russian Federation