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腹主动脉瘤综合多中心生物库的设计和方案。

Design and protocol of a comprehensive multicentre biobank for abdominal aortic aneurysms.

机构信息

Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Department of Surgery, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

出版信息

BMJ Open. 2019 Aug 1;9(8):e028858. doi: 10.1136/bmjopen-2018-028858.

DOI:10.1136/bmjopen-2018-028858
PMID:31375618
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6688677/
Abstract

INTRODUCTION

The pathophysiology and natural course of abdominal aortic aneurysms (AAAs) are insufficiently understood. In order to improve our understanding, it is imperative to carry out longitudinal research that combines biomarkers with clinical and imaging data measured over multiple time points. Therefore, a multicentre biobank, databank and imagebank has been established in the Netherlands: the '' (AAA bank).

METHODS AND ANALYSIS

The AAA bank is a prospective multicentre observational biobank, databank and imagebank of patients with an AAA. It is embedded within the framework of the Parelsnoer Institute, which facilitates uniform biobanking in all university medical centres (UMCs) in the Netherlands. The AAA bank has been initiated by the two UMCs of Amsterdam UMC and by Leiden University Medical Center. Participants will be followed during AAA follow-up. Clinical data are collected every patient contact. Three types of biomaterials are collected at baseline and during follow-up: blood (including DNA and RNA), urine and AAA tissue if open surgical repair is performed. Imaging data that are obtained as part of clinical care are stored in the imagebank. All data and biomaterials are processed and stored in a standardised manner. AAA growth will be based on multiple measurements and will be analysed with a repeated measures analysis. Potential associations between AAA growth and risk factors that are also measured on multiple time points can be assessed with multivariable mixed-effects models, while potential associations between AAA rupture and risk factors can be tested with a conditional dynamic prediction model with landmarking or with joint models in which linear mixed-effects models are combined with Cox regression.

ETHICS AND DISSEMINATION

The AAA bank is approved by the Medical Ethics Board of the Amsterdam UMC (University of Amsterdam).

TRIAL REGISTRATION NUMBER

NCT03320408.

摘要

简介

腹主动脉瘤(AAA)的病理生理学和自然病程尚未得到充分理解。为了提高我们的认识,必须开展结合生物标志物与多次时间点测量的临床和影像学数据的纵向研究。因此,荷兰建立了一个多中心生物库、数据库和图像库:“AAA 银行”。

方法与分析

AAA 银行是一个前瞻性的多中心观察性生物库、数据库和图像库,用于收集 AAA 患者的信息。它嵌入在 Parelsnoer 研究所的框架内,该研究所便利了荷兰所有大学医学中心(UMC)的统一生物库建设。AAA 银行由阿姆斯特丹 UMC 和莱顿大学医学中心两家 UMC 发起。参与者将在 AAA 随访期间接受随访。临床数据在每次患者就诊时收集。在基线和随访期间收集三种生物材料:血液(包括 DNA 和 RNA)、尿液和如果进行开放性外科修复,则收集 AAA 组织。作为临床护理一部分获得的影像学数据存储在图像库中。所有数据和生物材料都以标准化方式进行处理和存储。AAA 生长将基于多次测量,并通过重复测量分析进行分析。可以使用多变量混合效应模型评估 AAA 生长与也在多个时间点测量的风险因素之间的潜在关联,而可以使用条件动态预测模型进行 AAA 破裂与风险因素之间的潜在关联的测试,或使用联合模型,其中将线性混合效应模型与 Cox 回归相结合。

伦理与传播

AAA 银行获得了阿姆斯特丹 UMC(阿姆斯特丹大学)医学伦理委员会的批准。

临床试验注册号

NCT03320408。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/413c/6688677/8c4f6e5aa41e/bmjopen-2018-028858f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/413c/6688677/8c4f6e5aa41e/bmjopen-2018-028858f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/413c/6688677/8c4f6e5aa41e/bmjopen-2018-028858f01.jpg

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