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Background <p>Although cancer antigen 19–9 (CA 19–9) is the only FDA-approved biomarker for pancreatic ductal adenocarcinoma (PDAC), its diagnostic effectiveness is limited, as it may not be elevated in 15–25% of patients. This study aims to explore novel plasma proteins associated with PDAC as potential biomarkers for early diagnosis and clinical surveillance.</p> Methods <p>Novel plasma protein biomarkers potentially causally associated with PDAC were identified using Mendelian randomization (MR). These biomarkers were validated in a multicenter study encompassing 230 tissue and 1,011 plasma samples to establish a diagnostic model for PDAC. Furthermore, their pre- and post-operative levels were compared to evaluate their potential as clinical surveillance biomarkers.</p> Results <p>Genetically predicted expression of seven proteins potentially causally associated with an increased risk of PDAC. In a multicenter, large-scale study, Keratin 5 (KRT5) and Versican (VCAN) were identified as promising biomarkers for PDAC, with an area under the curve (AUC) of 0.90, and a combined panel including CA 19–9 achieved an AUC of 0.95. Additionally, plasma KRT5 and VCAN demonstrated superior diagnostic performance for early-stage PDAC with CA 19–9 levels below 37 U/mL (Stage I, AUC 0.85; Stage II, AUC 0.85). The specificity of plasma KRT5 and VCAN for PDAC was further validated by comparing their expression levels across various digestive cancers. Moreover, a significant decrease in plasma KRT5 and VCAN levels was observed post-surgery (<i>P</i> &lt; 0.05), supporting their potential as biomarkers for clinical surveillance of PDAC.</p> Conclusions <p>Plasma KRT5 and VCAN proteins may serve as promising valuable biomarkers for the early diagnosis and clinical surveillance of PDAC.</p>

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Identification of novel plasma proteins as promising noninvasive biomarker for early diagnosis and surveillance of pancreatic ductal adenocarcinoma

  • 期刊论文

  • 发表日期：

    2025年4月26日

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  • Shuang Liu,
  • Jiachun Su,
  • Hongzhe Zhao,
  • Ruihong Bai,
  • Lingxing Zeng,
  • Chunling Xue,
  • Shuang Deng,
  • Shaoqiu Liu,
  • Ziming Chen,
  • Zilan Xu,
  • Yifan Zhou,
  • Sihan Zhao,
  • Xiaoyu Wu,
  • Xinyi Peng,
  • Jialiang Zhang,
  • Xudong Huang,
  • Jian Zheng,
  • Chongyu Zhao,
  • Lu Zheng

摘要

Background

Although cancer antigen 19–9 (CA 19–9) is the only FDA-approved biomarker for pancreatic ductal adenocarcinoma (PDAC), its diagnostic effectiveness is limited, as it may not be elevated in 15–25% of patients. This study aims to explore novel plasma proteins associated with PDAC as potential biomarkers for early diagnosis and clinical surveillance.

Methods

Novel plasma protein biomarkers potentially causally associated with PDAC were identified using Mendelian randomization (MR). These biomarkers were validated in a multicenter study encompassing 230 tissue and 1,011 plasma samples to establish a diagnostic model for PDAC. Furthermore, their pre- and post-operative levels were compared to evaluate their potential as clinical surveillance biomarkers.

Results

Genetically predicted expression of seven proteins potentially causally associated with an increased risk of PDAC. In a multicenter, large-scale study, Keratin 5 (KRT5) and Versican (VCAN) were identified as promising biomarkers for PDAC, with an area under the curve (AUC) of 0.90, and a combined panel including CA 19–9 achieved an AUC of 0.95. Additionally, plasma KRT5 and VCAN demonstrated superior diagnostic performance for early-stage PDAC with CA 19–9 levels below 37 U/mL (Stage I, AUC 0.85; Stage II, AUC 0.85). The specificity of plasma KRT5 and VCAN for PDAC was further validated by comparing their expression levels across various digestive cancers. Moreover, a significant decrease in plasma KRT5 and VCAN levels was observed post-surgery (P < 0.05), supporting their potential as biomarkers for clinical surveillance of PDAC.

Conclusions

Plasma KRT5 and VCAN proteins may serve as promising valuable biomarkers for the early diagnosis and clinical surveillance of PDAC.