Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
NCT Number: NCT06549725
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreas Cancer|Pancreatic Ductal Adenocarcinoma|Hereditary Diseases|Pancreatitis, Chronic
Interventions: DEVICE: software Lipidica|PROCEDURE: endoscopic ultrasonography|PROCEDURE: magnetic resonance|DIAGNOSTIC_TEST: laboratory examination|PROCEDURE: computed tomography
Sponsor: Lipidica, a.s.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 419
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING
Start Date: 2024-08-26
Completion Date: 2027-08-26
Locations: Fakultni nemocnice Brno, Brno, Czechia|Fakultni nemocnice u sv. Anny, Brno, Czechia|Masarykuv onkologicky ustav, Brno, Czechia|Fakultni nemocnice Hradec Kralova, Hradec Králové, Czechia|Fakultni nemocnice Olomouc, Olomouc, Czechia|Nemocnice Pardubickeho kraje, Pardubice, Czechia|Fakultni nemocnice Plzen, Plzen, Czechia|Fakultni nemocnice Bulovka, Praha, Czechia|Fakultni nemocnice Kralovske Vinohrady, Praha, Czechia|Fakultni Thomayerova nemocnice, Praha, Czechia|Institut klinicke a experimentalni mediciny, Praha, Czechia|Vseobecna fakultni nemocnice, Praha, Czechia|Masarykova nemocnice v Usti nad Labem, Ústí Nad Labem, Czechia|Nemocnice Ceske Budejovice, České Budějovice, Czechia

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 MDSW 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

Primary Outcome Measures: The primary objective is to verify that the investigational MDSW 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, Interim analysis 1 year from first subject enrolled and through study completion (an average of 3 years)
Other Outcome Measures: Glycosylated haemoglobin (HbA1c) levels with PaC diagnosis status, The association of glycosylated haemoglobin (HbA1c) levels with PaC diagnosis status. Measured in both arms., Through study completion (an average of 3 years)|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., Through study completion (an average of 3 years)|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 MDSW processing on sensitivity and specificity will be assessed. Measured in both arms., Through study completion (an average of 3 years)|The effect of the normalization step on the calculation of lipid concentrations and its impact on the clinical performance of MDSW., The effect of the normalization step on the calculation of lipid concentrations and its impact on the clinical performance of MDSW. 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 MDSW "Lipidica" is ≤ 0.5 for the healthy population. The expected value for patients with PaC is \> 0.5., Through study completion (an average of 3 years)|Verification of the clinical performance of next version(s) of MDSW "Lipidica", Verification of the clinical performance of next version(s) of MDSW "Lipidica" in alignment with the intended purpose using the laboratory and clinical data obtained in this CPS (i.e. to verify that new version(s) can still discriminate between samples of patients with PaC and persons without PaC but at higher risk of this cancer disease). Sponsor will assess the clinical function of the next version of MDSW "Lipidica" on key diagnostic parameters of the method in alignment with the primary outcome of the study and in comparison to the previous version which is the studied device: 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 MDSW "Lipidica" is ≤ 0.5 for the healthy population. The expected value for patients with PaC is \> 0.5., Through study completion (an average of 3 years)