Pilot study of screening method for pancreatic cancer using lipidomic profiling of plasma or serum.

[BACKGROUND] Pancreatic cancer is one of the most aggressive malignancies with a 5-year relative survival rate of only 13%. Its poor prognosis is largely attributed to the lack of reliable tools for early detection. Current diagnostic standards rely on imaging methods that are invasive, costly, and often inadequate to detect early-stage disease. A noninvasive blood-based test with high sensitivity and specificity could substantially improve patient outcomes.

[METHODS] Lipid concentrations in plasma and serum samples were determined by ultrahigh-performance supercritical fluid chromatography-mass spectrometry, and multivariate statistical modeling was used to analyze lipid profiles and differentiate between groups.

[RESULTS] Here, we present results from a pilot study evaluating lipidomic profiling of prospectively collected plasma and serum samples from patients with pancreatic ductal adenocarcinoma (PDAC, n = 177), healthy controls (n = 218), and high-risk individuals for pancreatic cancer (n = 93). The lipidomic test distinguishes PDAC patients from healthy controls with an accuracy exceeding 95%, including robust detection of early-stage cases and even individuals with low CA 19-9 secretion. The sensitivity is approximately 30% higher than that of CA 19-9. In high-risk individuals, the method achieves a specificity of over 96% (95% CI, 89-99%), comparable to established imaging-based approaches.

[CONCLUSIONS] This pilot study demonstrates the promising potential of lipidomic profiling as a noninvasive, blood-based screening tool for pancreatic cancer. The method outperforms current biomarkers, maintains high diagnostic accuracy in early-stage disease, and performs reliably in high-risk populations. These findings support the initiation of a clinical trial aimed at validating the lipidomic test for the early detection of PDAC.