Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform: Evolution of the Therapeutic Care in Lung Cancer in France Since 2015
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UNICANCER
- 入组人数
- 75,000
- 试验地点
- 42
- 主要终点
- Patient characteristics
研究概览
简要总结
This database compiles data from existing data available from patient's electronic medical records (EMR) at the 38 participating hospitals (20 French comprehensive cancer centers and 18 public hospitals).
详细描述
The database includes data related to patient demographics, tumor characteristics (diagnosis, histology, relapses, metastatic disease, etc.), treatments (dates, INN, route of administration, treatment protocols, reason for termination, etc.), and clinical events. Data is collected at each participating site by technicians who are specifically trained for the project using an electronic data collection (eDC) tool.
Data imported into the final database are controlled, recoded, and harmonized before import according to the data management plan. All coding procedures are predefined by the data manager. There is no transmission of individual data; all data are centralized within each center using a shared anonymous format. All data is exclusively obtained retrospectively; no attempts are made to recover non available data from the patient's medical record by contacting healthcare providers or patients.
ESME LC Data Platform aims to be a clinical and therapeutic database centralizing existing and available data from different sources used in the participating sites.
Data do not contain any personal data on patients. In compliance with the authorization delivered by the French Data Protection agency to Unicancer, only aggregated statistical reports and publication are released.
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 (over 18)
- •Treated (with radiotherapy or systemic anti-cancer treatment) for a lung cancer or diagnosed with metastatic lung cancer over the selection period at one of the participating site
排除标准
- 未提供
结局指标
主要结局
Patient characteristics
时间窗: Baseline
Age in years, Tobacco consumption, other exposures, Legal recognition as occupational disease, Medical history, History of other cancer, weight in kg and performance status (ECOG)
Tumor characteristics
时间窗: Baseline
Staging, Tumor size, sampling Method, histological type
Treatment patterns
时间窗: From Baseline until 2024 (yearly basis)
Drug, therapeutic class, treatment duration at each n treatment line
次要结局
- Median overall survival(From date of diagnosis or first treatment until the date of death from any cause. Follow up until 2024)
- Median surrogate endpoints for overall survival(From start date of the nth treatment line until the date of first applicable event. Follow up until 2024)
