Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Database : Evolution of the Therapeutic Care in Ovarian Cancer Across the French Comprehensive Cancer Centers From 2011
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- UNICANCER
- 入组人数
- 13,331
- 试验地点
- 31
- 主要终点
- Describe the evolution of therapeutic care in ovarian cancer across the French comprehensive cancer centers
研究概览
简要总结
The ESME Ovarian Cancer database is a multi-center real life database using a retrospective data collection process in 18 French Comprehensive Cancer Center (FCCC) over 20 sites). This database compiles data from existing data available from patient's electronic medical records (EMR).
详细描述
This database compiles data from existing data available from patient's electronic medical records (EMR) and integrates data from non-structured ans structured sources.
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 OC database aims to be a clinical and therapeutic database centralizing existing and available data from different sources used in the participating hospitals. 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
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old female
- •Female who received surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, diagnostic procedure, other specific therapeutic procedure) for ovarian cancer in a French Comprehensive Cancer Center.
排除标准
- 未提供
研究组 & 干预措施
Ovarian cancer cohort
Any female treated for ovarian cancer in a French comprehensive cancer centers
结局指标
主要结局
Describe the evolution of therapeutic care in ovarian cancer across the French comprehensive cancer centers
时间窗: baseline
Patient characteristics, tumor characteristics and treatment patterns
次要结局
- Describe the impact of therapeutic strategies on survival criteria(From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2022.)
