跳至主要内容
临床试验/NCT03848052
NCT03848052招募中不适用

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

UNICANCER42 个研究点 分布在 1 个国家目标入组 75,000 人开始时间: 2017年10月2日最近更新:
适应症

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

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)

研究者

发起方
UNICANCER
申办方类型
Other
责任方
Sponsor

研究点 (42)

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