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
Age ≥ 18 years
Signed informed consent
Histologically confirmed diagnosis of resectable PaC
History of any other cancer disease
Present incurable malignancy
Unfit for radical curative resection of the tumor
Vegan or vegetarian diet
Parallel
software Lipidica
DeviceThe 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
Procedure/SurgeryEndoscopic ultrasonography - maximum frequency: 3 times during the participation
magnetic resonance
Procedure/SurgeryMagnetic resonance - maximum frequency: 3 times during the participation
laboratory examination
Diagnostic testLipidomic analysis, CA 19-9, CEA, HbA1c and hCG levels assessment (hCG only in women of childbearing potential in Arm 2)
computed tomography
Procedure/Surgerycomputed tomography - maximum frequency: 3 times during the participation
The primary objective is to verify that the investigational IVDSW can discriminate between results of patients with PaC and persons without PaC but at higher risk of this cancer disease due to their predispositions.
The primary objective will be assessed using the following parameters: Diagnostic sensitivity The sensitivity is defined as the capacity to correctly detect confirmed positive samples of plasma from patient with PaC diagnosed with standard diagnostic methods. Diagnostic specificity The specificity is the ability to correctly classify samples of plasma from patient without PaC but at higher risk of the disease. The diagnosis of PaC will be excluded using standard diagnostic methods. Positive predictive value It is the ratio of patients with PaC truly diagnosed as positive to all those who had positive results (including healthy subjects who were incorrectly diagnosed as patients with PaC). Negative predictive value It is the ratio of subjects truly diagnosed as negative to all those who had negative results (including patients with PaC who were incorrectly diagnosed as healthy). Likelihood ratio and Expected values in normal and affected populations
Glycosylated haemoglobin (HbA1c) levels with PaC diagnosis status
The association of glycosylated haemoglobin (HbA1c) levels with PaC diagnosis status. Measured in both arms.
Effect of CA 19-9 and CEA tumor markers on sensitivity and specificity
The effect of CA 19-9 and CEA tumor markers input into the mathematical model as an integral part of MDSW used for processing data derived from lipidomic testing on sensitivity and specificity. Measured in both arms.
Several predefined cut-off values
Sensitivity and specificity will be assessed for several predefined cut-off values to explore the impact of the results within the range of diagnostic uncertainty. The impact of subgroups within different ranges of results based on IVDSW processing on sensitivity and specificity will be assessed. Measured in both arms.
The effect of the normalization step on the calculation of lipid concentrations and its impact on the clinical performance of IVDSW.
The effect of the normalization step on the calculation of lipid concentrations and its impact on the clinical performance of IVDSW. Sponsor will assess the impact of normalization which automatically eliminates the effect of mass spectrometer aging on key diagnostic parameters of the method in alignment with the primary outcome of the study: Diagnostic sensitivity, Diagnostic specificity, Positive predictive value, Negative predictive value, Likelihood ratio, Expected values in normal and affected populations. The expected value of the result from IVDSW "Lipidica" is ≤ 0.5 for the healthy population. The expected value for patients with PaC is \> 0.5.
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