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Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
Sponsor: Lipidica, a.s.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
419
Start Date
2024-09-10
Completion Date
2027-09-26
Last Updated
2025-08-01
Healthy Volunteers
Yes
Interventions
software Lipidica
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
Endoscopic ultrasonography - maximum frequency: 3 times during the participation
magnetic resonance
Magnetic resonance - maximum frequency: 3 times during the participation
laboratory examination
Lipidomic analysis, CA 19-9, CEA, HbA1c and hCG levels assessment (hCG only in women of childbearing potential in Arm 2)
computed tomography
computed tomography - maximum frequency: 3 times during the participation
Locations (16)
Ustredni vojenska nemocnice
Prague, Czechia, Czechia
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice u sv. Anny
Brno, Czechia
Masarykuv onkologicky ustav
Brno, Czechia
Nemocnice Ceske Budejovice
České Budějovice, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Nemocnice Jablonec nad Nisou
Jablonec nad Nisou, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Nemocnice Pardubickeho kraje
Pardubice, Czechia
Fakultni nemocnice Plzen
Pilsen, Czechia
Fakultni nemocnice Bulovka
Prague, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Fakultni Thomayerova nemocnice
Prague, Czechia
Institut klinicke a experimentalni mediciny
Prague, Czechia
Vseobecna fakultni nemocnice
Prague, Czechia
Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, Czechia