细胞外囊泡（EV）是癌症诊断早期生物标志物的一个有前景的来源。它们富含多种分子内容，如蛋白质、DNA、mRNA、miRNA、脂质和代谢物。 EV 蛋白作为潜在的生物标志物已被广泛研究，因为它们反映了特定的患者状况。然而，尽管许多标记物已使用外部患者队列和不同的分析方法进行了验证和确认，但没有 EV 蛋白标记物被批准用于诊断用途。本综述介绍了使用质谱和基于免疫的技术来识别和验证 EV 蛋白生物标志物所采用的主要策略。我们报告并讨论了最近的科学研究，重点是通过 EV 发现癌症生物标志物，强调它们在几种癌症类型的快速诊断方面的巨大潜力。最后，介绍了通过开发易于使用和高通量的样品制备试剂盒，在 EV 分离和定量标准化方面取得的最新进展，这将使蛋白质 EV 生物标志物更加可靠和易于使用。这里报告的数据表明，在蛋白囊泡标记物成为诊断癌症的重要工具之前，仍然存在一些挑战需要解决。版权所有 © 2024 Elsevier Ltd. 保留所有权利。

Extracellular vesicles (EVs) are a promising source of early biomarkers for cancer diagnosis. They are enriched with diverse molecular content, such as proteins, DNA, mRNA, miRNA, lipids, and metabolites. EV proteins have been widely investigated as potential biomarkers since they reflect specific patient conditions. However, although many markers have been validated and confirmed using external cohorts of patients and different analytical approaches, no EV protein markers are approved for diagnostic use. This review presents the primary strategies adopted using mass spectrometry and immune-based techniques to identify and validate EV protein biomarkers. We report and discuss recent scientific research focusing on cancer biomarker discovery through EVs, emphasizing their significant potential for the tempestive diagnosis of several cancer typologies. Finally, recent advancements in the standardization of EV isolation and quantitation through the development of easy-to-use and high-throughput kits for sample preparation-that should make protein EV biomarkers more reliable and accessible-are presented. The data reported here showed that there are still several challenges to be addressed before a protein vesicle marker becomes an essential tool in diagnosing cancer.Copyright © 2024 Elsevier Ltd. All rights reserved.