NCT00831909CompletedNot Applicable
Epidemiological Study to Describe Non-small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Europe. Lung
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 3,513
- Locations
- 1
- Primary Endpoint
- To provide accurate, reliable information on NSCLC clinical management across European countries in order to detect unmet medical needs of this disease
Study Overview
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.
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. 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,
- •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.
Outcomes
Primary Outcomes
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
Secondary 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 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 clinical outcomes (patient, disease stage and clinical management related factors): predictive modelling for improved patient outcome.(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)
Investigators
Study Sites (1)
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