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RECRUITING
NCT06549725
NA

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

Sponsor: Lipidica, a.s.

View on ClinicalTrials.gov

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

DEVICE

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.

PROCEDURE

endoscopic ultrasonography

Endoscopic ultrasonography - maximum frequency: 3 times during the participation

PROCEDURE

magnetic resonance

Magnetic resonance - maximum frequency: 3 times during the participation

DIAGNOSTIC_TEST

laboratory examination

Lipidomic analysis, CA 19-9, CEA, HbA1c and hCG levels assessment (hCG only in women of childbearing potential in Arm 2)

PROCEDURE

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