Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
Lipidica, a.s.
419 participants
Sep 10, 2024
INTERVENTIONAL
Conditions
Summary
Software "Lipidica" is intended to be used for processing data generated by the in-house in vitro diagnostic medical device for lipidomic testing for the purpose of screening Pancreatic cancer (PaC) in the population at high risk of this cancer due to familial risk, selected gene mutations or hereditary pancreatic diseases. The primary objective is to verify that the investigational IVDSW can discriminate between results of patients with Pancreatic cancer and persons without Pancreatic cancer but at higher risk of this cancer disease due to their predispositions. Participants will: * come to baseline and end of study visit for blood sampling and medical imaging * some participant will undertake one more visit depending on their results on baseline
Eligibility
Inclusion Criteria17
- 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)
Exclusion Criteria9
- History of any other cancer disease
- Present incurable malignancy
- Unfit for radical curative resection of the tumor
- Vegan or vegetarian diet
- Pregnancy of planning to conceive in the next 12 months
- History of any cancer disease
- Present incurable malignancy
- Inability to undergo planned medical imaging or blood sampling
- Vegan or vegetarian diet
Interventions
The investigational in vitro diagnostic medical device-software (IVDSW) "Lipidica" processes and analyses data inputs from the analysis of lipid profile in human plasma using an in-house in vitro diagnostic medical device.
Endoscopic ultrasonography - maximum frequency: 3 times during the participation
Magnetic resonance - maximum frequency: 3 times during the participation
Lipidomic analysis, CA 19-9, CEA, HbA1c and hCG levels assessment (hCG only in women of childbearing potential in Arm 2)
computed tomography - maximum frequency: 3 times during the participation
Locations(16)
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NCT06549725