Validation of the Data Quality and Early Outcomes of the Spanish EURECCA Esophagogastric Cancer Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,839
- 试验地点
- 11
- 主要终点
- Data integrity
研究概览
简要总结
Objective. The objective of the study is to verify and validate the data collected in the Spanish EURECCA (EUropean REgistry of Cancer CAre) Esophagogastric Cancer Registry between January 2014 and December 2017 through an audit process. It is also intended to describe the initiation and implementation of this Registry as well as its early outcomes.
Methods. An audit of registered cases (esophageal, esophagogastric junction and gastric cancer resectable patients undergoing surgery) from 01/01/2014 to 12/31/2017 and a descriptive analysis of these data will be performed.
Expected results. The study could show that the Spanish EURECCA Esophagogastric Cancer Registry is a reliable source of information, valid for carrying out specific and exhaustive analysis that may lead to high quality publications in indexed journals. It is also expected to generate a high impact based on the large number of cases included in the Registry, favoring new research projects.
Relevance. The standardization of the data collection is essential to compare outcomes between different centers, regions and countries. This study will allows us to verify the integrity of the collected data as well as its accuracy, a critical aspect to gain credibility for future studies using the Registry data.
详细描述
The overall objective of the project is to verify and validate the data collected in the Spanish EURECCA Esophagogastric Cancer Registry through an audit process.
The project is divided into two sub-studies.
For sub-study 1 (data audit) the specific objectives are:
- To verify the integrity of the cases.
- To check the accuracy of the data.
For sub-study 2 (descriptive analysis) the specific objectives are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with esophageal, esophagogastric and gastric cancer candidates for radical resection
排除标准
- •metastatic patients
- •patients candidates for palliative treatment
- •patients without a signed informed consent
结局指标
主要结局
Data integrity
时间窗: 6 months
Determinig the case ascertainment percentage for the Spanish EURECCA Registry
Data accuracy
时间窗: 6 months
Verification of the accuracy in the collection of 23 selected variables in the Spanish EURECCA Registry for every patient
次要结局
未报告次要终点
研究者
Manuel Ramón Pera Román
Professor of Surgery, Head of Section of Gastrointestinal Surgery
Parc de Salut Mar
