The Potential Diagnostic Value of Serum microRNA Signature in Patients with Pancreatic Cancer

Abstract

Biomarkers for early diagnosis of patients with pancreatic cancer (PC) are needed. Our aim was to identify panels of miRNAs in serum in combination with CA 19-9 for use in the diagnosis of PC. Four hundred seventeen patients with PC were included prospectively from Denmark (n=306) and Germany (n=111). Controls included 59 patients with chronic pancreatitis (CP) and 248 healthy subjects (HS). MiRNAs were analyzed in pre-treatment serum samples from 3 cohorts: discovery cohort (754 human miRNAs, TaqMan® Human MicroRNA assay, Applied Biosystem; PC n=133, controls n=72); training cohort (34 miRNAs, real-time qPCR using the Fluidigm BioMarkTM System; PC n=198, controls n=184); validation cohort (13 miRNAs, real-time qPCR using the Fluidigm BioMarkTM System; PC n=86, controls n=51). We found that 34 miRNAs in serum from PC patients in the discovery cohort were expressed differently than in controls. These miRNAs were tested in the training cohort, and 4 diagnostic panels were constructed that included 5 or 12 miRNAs (miR-16, -18a, -20a, -24, -25, -27a, -29c, -30a.5p, -191, -323.3p, -345, -483.5p). Diagnostic accuracy of detecting PC in the training cohort was AUC (index I 0.85; II 0.87; III 0.85; IV 0.95; CA 19-9 0.93); specificity (I 0.71; II 0.76; III 0.66; IV 0.90 (fixed sensitivity at 0.85); CA 19-9 0.93). Combining serum CA 19-9 and index II best discriminated stages I and II PC from HS (AUC 0.93 (0.90–0.96); sensitivity 0.77 (0.69–0.84); specificity 0.94(0.90–0.96); accuracy 0.88 (0.84–0.91)). In conclusion, we identified 4 diagnostic panels based on 5 or 12 miRNAs in serum that could distinguish patients with PC from HS and CP. This article is protected by copyright. All rights reserved.

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