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随机对照试验中的血液样本采集用于生物标志物发现和验证:PREOPANC-2试验的经验

Esther N Dekker¹, Quisette P Janssen¹, Jacob L van Dam¹

¹Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.

Annals of surgical oncology

|February 5, 2025

概括

在全国性随机对照试验 (RCT) 中采集血液样本实现了87%的总产量,证明了生物标志物研究的可行性. 在处理前观察到高收集率,支持其在大规模研究中的实用性.

科学领域:

在瘤学瘤学.
临床试验临床试验
生物标志物研究生物标志物研究

背景情况:

研究血液样本采集的可行性和产量对于大规模的临床研究至关重要.
PREOPANC-2试验是一项全国性随机对照试验 (RCT),专注于胰腺癌治疗.

研究的目的:

评估血液样本采集在全国随机对照试验 (RCT) 中的可行性和产量.
为了确定胰腺癌患者在治疗期间和治疗后在多个时间点收集血液样本的成功率.

主要方法:

在PREOPANC-2试验中,在19个中心注册了375名患有切除胰腺癌的患者.
计划在七个时间点收集血液样本:在新辅助治疗和手术之前,期间和之后.
衡量的主要结果是每个预定时间点成功采集血液样本的比例.

主要成果:

在1748个计划样本中,有1513个 (87%) 成功收集,处理和存储.
收集率在治疗前很高 (96%),随着时间的推移下降,24个月后收集了77%.
缺少样本的常见原因包括调度错误,抽签失败,邮件问题和COVID-19相关的取消.

结论:

在PREOPANC-2试验中采集血液样本显示出高收益率 (87%总体, 96%治疗前).
该研究证实了在全国范围的RCT环境中收集血液样本用于生物标志物研究的可行性.
尽管有COVID-19等挑战,但已建立的协议支持对未来研究进行强有力的样本采集.

关键词:

生物标志物生物标志物胰腺癌是一种胰腺癌.个性化医疗是个性化的医疗.随机对照试验是随机对照试验.

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