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

Prior treatment

• Unfit for radical curative resection of the tumor

Other illness

• History of any other cancer disease
• Present incurable malignancy
• History of any cancer disease
• Present incurable malignancy

Other

• Vegan or vegetarian diet
• Pregnancy of planning to conceive in the next 12 months
• Inability to undergo planned medical imaging or blood sampling
• Vegan or vegetarian diet

• Age ≥ 18 years
• Signed informed consent
• Histologically confirmed diagnosis of resectable PaC
• Age ≥ 18 years
• Signed informed consent
• High risk of PaC due to the presence of one of the following risk factors:
  • Family history of PaC (≥ 2 first-degree or second-degree relatives with PaC in the same family line)
  • Confirmed germline mutation of STK11 (LKB1) regardless of family history
  • Confirmed germline mutation of CDKN2A leading to the alteration of p16 regardless of family history
  • Confirmed germline mutation of APC, ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2 or TP53 AND ≥ 1 first-degree or second-degree relative with PaC
  • Present hereditary pancreatitis (recurrent acute pancreatitis or chronic pancreatitis and confirmed germline mutation of PRSS1)
• Age:
  • Person with a family history of PaC: \> 50 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
  • Person with STK11 mutation: \> 35 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
  • Person with CDKN2A mutation: \> 40 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
  • Person with APC, ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2 or TP53 mutation: \> 45 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
  • Person with hereditary pancreatitis: \> 40 years or 20 years after the 1st attack (whichever comes first)