Development of novel diagnostic system for pancreas cancer including early stages measuring mRNA of whole blood cells

Summary

Pancreatic ductal adenocarcinoma (PDAC) is the most life‐threating disease among all digestive system malignancies. We developed a blood mRNA PDAC screening system using real‐time detection PCR to detect the expression of 56 genes, to discriminate PDAC from non‐cancer subjects. We performed a clinical study to assess the performance of the developed system. We collected whole blood RNA from 53 PDAC patients, 102 non‐cancer subjects, 22 patients with chronic pancreatitis, and 23 patients with intraductal papillary mucinous neoplasms (IPMNs) in a per protocol analysis. The sensitivity of the system for PDAC diagnosis was 73.6% (95% confidence interval 59.7%–84.7%). The specificity for non‐cancer volunteers, chronic pancreatitis, and IPMN patients was 64.7% (54.6%–73.9%), 63.6% (40.7%–82.8%), and 47.8% (26.8%–69.4%), respectively. Importantly, the sensitivity of this system for both stage I and stage II PDAC was 78.6% (57.1%–100%), suggesting that detection of PDAC by the system is not dependent on the stage of PDAC. These results indicated that the screening system, relying on assessment of changes in mRNA expression in blood cells, is a viable alternative screening strategy for PDAC.

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