A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 25
- 主要终点
- NSCLC treatment approaches in Real-World practice
研究概览
简要总结
This is a non-interventional, retrospective observational study to improve knowledge regarding the diagnosis and treatments of patients who have/had non-small cell lung cancer (NSCLC), either early stage (stage I-II).
详细描述
Due to heterogeneity of patients with stage I-III Non Small Cell Lung Cancer (NSCLC), there is not a unique common therapeutic approach and there is no consensus about the optimal timing, sequencing and combination of surgery, chemotherapy and radiotherapy across the spectrum of early stage and locally advance disease. Consequently, the choice of local treatment modality can vary across countries and centers.
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
- •Patients with stage I-III NSCLC who have received curative surgery or radiotherapy between January 2018 and June 2019 with available follow-up through January 2021
- •Adult patients (aged ≥ 18 years) at the moment of diagnosis
- •Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent form; privacy Form (ICF). In case of deceased or untraceable patient the investigator before collecting data shall demonstrate and report all necessary measures adopted to contact the patient.
排除标准
- •Patients without availability of medical charts or information required
- •Enrollment in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.
结局指标
主要结局
NSCLC treatment approaches in Real-World practice
时间窗: Restrospective data capture from January 2018 to January 2021.
Percentage of patients undergoing to: 1. surgical resection of the lung cancer with curative intent; 2. definitive (chemo)radiotherapy (defined as any regimen of chemotherapy administered with concurrent radiotherapy) 3. neoadjuvant treatment (4 cycles) before surgery 4. adjuvant treatments (4 cycles) after surgery
Percentage of patients discusses in multidisciplinary team
时间窗: Restrospective data capture from January 2018 to January 2021
Multidisciplinary team defined as the involvement of radiotherapy unit, pneumology and/or interventional pneumology unit in patient discussion.
Healthcare resource utilization aof different therapeutic approaches
时间窗: Restrospective data capture from January 2018 to January 2021.
Healthcare resources used to manage the patients will be described in terms of lab tests and/or outpatient visits and/or drug therapy and/or diagnostic tests.
Direct medical costs of different therapeutic approaches
时间窗: Restrospective data capture from January 2018 to January 2021.
The cost of the therapeutic approach (cost of illness) will be estimated through an activity-based costing (ABC) technique which allows to calculate the full cost of a service by measuring the cost of each individual activity/resource related to it.
次要结局
- NSCLC treatments timeline in Real-World practice(Restrospective data capture from January 2018 to January 2021.)