NCT01069835CompletedNot Applicable
Epidemiological Study to Describe NSCLC Clinical Management Patterns in Central Eastern Europe and Russia. Lung-EPICLIN
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 840
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Time Frame: 24 months
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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