NCT01069835已完成不适用
Epidemiological Study to Describe NSCLC Clinical Management Patterns in Central Eastern Europe and Russia. Lung-EPICLIN
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Mixed histology of small cell and non-small cell lung cancer.
结局指标
主要结局
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
时间窗: 24 months
次要结局
- 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)
研究者
研究点 (1)
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