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临床试验/NCT03541629
NCT03541629已完成不适用

Validation of the Data Quality and Early Outcomes of the Spanish EURECCA Esophagogastric Cancer Registry

Parc de Salut Mar11 个研究点 分布在 1 个国家目标入组 1,839 人开始时间: 2018年7月26日最近更新:
适应症

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

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

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manuel Ramón Pera Román

Professor of Surgery, Head of Section of Gastrointestinal Surgery

Parc de Salut Mar

研究点 (11)

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