Clinical Performance of Medical Device Software Lipidica 1.0 for Processing Lipidomic Data in Pancreatic Cancer Screening

What this Trial Is About

This research aims to evaluate the software "Lipidica 1.0," designed to process lipidomic data from an in-house diagnostic device, for screening pancreatic cancer (PaC) in people at high risk due to family history, gene mutations, or hereditary pancreatic diseases. Pancreatic cancer often has a poor prognosis due to late detection and rapid progression. Early screening in high-risk groups may improve outcomes, and this study builds on previous findings showing distinct lipid profiles in pancreatic cancer patients. Participants are divided into two groups: those with confirmed resectable pancreatic cancer, who will have one baseline visit for blood sampling to analyze lipid profiles and tumor markers; and those at high risk without cancer, who will have two or three visits over up to 12 months. The high-risk group undergoes blood tests and medical imaging such as endoscopic ultrasonography, magnetic resonance, or computed tomography. The software's ability to distinguish between cancer patients and high-risk individuals without cancer is the main focus. Participants will attend visits for blood collection and imaging at the start and end of the study, with some having an additional visit based on initial results. Blood tests include lipidomic analysis, tumor markers CA 19-9 and CEA, HbA1c, and hCG for women of childbearing potential. Imaging assessments occur up to three times per participant. Researchers will analyze these data to verify the software's performance in differentiating disease presence. The study is expected to continue for about three years, with interim analysis after one year.

Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening