Multicentric Multinational Observational Study to Describe the Shift in Stage at Diagnosis of Lung Cancer. No Direct Recruitment of Patients or Administration of Study Medication.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 3,000
- 主要终点
- Early stage (stage I and II with [N0])
研究概览
简要总结
Multinational observational study to describe diagnostic stage shift in patients with lung cancer using medical records. Increased lung cancer screening programs and increased utilization of other screening modalities such as large increase in community chest radiography referral rates in response to public awareness campaigns, as well as unintentional detections through cardiac CT(computed tomography) angiograms, or screening for coronary disease may help in detecting the disease at earlier curable stages. Availability and increased access to novel therapies increase the likelihood of an early-stage diagnosis aiming for improved survival.
详细描述
This is a multicentric, multinational, observational study to describe the shift in stage at diagnosis of lung cancer over the time- period from baseline year to EOS (end of study). The study will be implemented in the AstraZeneca International Region (ie, non-US, non-European countries). The participating countries and sites will be selected based on the availability and accessibility of secondary data sources such as lung cancer databases or EMR (electronic medical records) in the target countries. Once countries and databases are selected, the protocol will be adapted for the specific country including details about the patient databases. The study will be conducted in compliance with the local legal, ethical, and regulatory requirements of the selected countries. The study-specific data will be extracted from the databases and recorded using eCRF (electronic case report form). This study does not involve direct recruitment of the patients. Aggregated data from the databases for each consecutive year starting from the baseline year until EOS, of patients with lung cancer meeting the inclusion criteria will be included in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult female and male patients ≥18 years old.
- •Confirmed diagnosis of lung cancer (either cytologically or histologically)
排除标准
- •Patients presenting with recurrent or relapsed lung cancer.
- •Patients with a concomitant cancer at the time of diagnosis of lung cancer, except for nonmetastatic nonmelanoma skin cancers, or in situ or benign neoplasms: a cancer will be considered concomitant if it occurs within 5 years of lung cancer diagnosis.
结局指标
主要结局
Early stage (stage I and II with [N0])
时间窗: 5 years
Number and percentage of patients diagnosed with Early stage (stage I and II with \[N0\]) from baseline year until EOS
Locally advanced (stage II and III [N+])
时间窗: 5 years
Number and percentage of patients diagnosed with Locally advanced (stage II and III \[N+\]) from baseline year until EOS
Late stage (stage IV [M1])
时间窗: 5 years
Number and percentage of patients diagnosed with Late stage (stage IV \[M1\]) from baseline year until EOS
次要结局
- screening based on clinical presentation(5 years)
- Incidental diagnosis(5 years)
- TNM staging(5 years)
- Histological type(5 years)