Trial Design: Currently, there are no clinically established biomarkers useful for early detection of PDAC. Serum CA19-9 is the most commonly used PDAC biomarker in the clinic. However, it is not present in 10% of individuals, and is elevated in various benign and malignant pancreato-biliary diseases, it is therefore, not recommended for early diagnostic purposes. Biomarkers with a performance superior to serum CA19-9 are thus likely to make an important impact on PDAC outcome. Currently, the diagnosis is usually made by imaging (such as contrast-enhanced CT or EUS), usually after late symptoms such as jaundice and weight loss have already appeared. Novel, highly accurate, non-invasive diagnostic tests would thus fill a major clinical need for screening patients at risk.
A three-biomarker panel (REG1, TFF1, LYVE1) for early detection of PDAC through proteomic profiling of clinical urine specimens has recently been developed. This has been validated in a large collection of PDAC and control patients’ samples using ELISA assays. The biomarkers appeared to be able to discriminate cancer from non-cancer patients with accuracy of around 90%. Based on these promising results, the urine biomarkers represent an exciting potential for future clinical application. The further validation of these three protein biomarkers will be performed in asymptomatic and symptomatic patients at risk for developing PDAC.
To improve even further the results from the three protein biomarkers, they will be combined with other biomarkers that have recently been identified, such as microRNAs, metal elements and volatile organic compounds (VOCs) in order to achieve highly accurate omics-based test for early PDAC detection.