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

NARecruitingINTERVENTIONAL
Enrollment

419

Participants

Timeline

Start Date

September 10, 2024

Primary Completion Date

September 26, 2027

Study Completion Date

September 26, 2027

Conditions
Pancreas CancerPancreatic Ductal AdenocarcinomaHereditary DiseasesPancreatitis, Chronic
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

Trial Locations (16)

Unknown

RECRUITING

Ustredni vojenska nemocnice, Prague

RECRUITING

Fakultni nemocnice Brno, Brno

RECRUITING

Fakultni nemocnice u sv. Anny, Brno

RECRUITING

Masarykuv onkologicky ustav, Brno

RECRUITING

Nemocnice Ceske Budejovice, České Budějovice

RECRUITING

Fakultni nemocnice Hradec Kralove, Hradec Králové

NOT_YET_RECRUITING

Nemocnice Jablonec nad Nisou, Jablonec nad Nisou

RECRUITING

Fakultni nemocnice Olomouc, Olomouc

RECRUITING

Nemocnice Pardubickeho kraje, Pardubice

RECRUITING

Fakultni nemocnice Plzen, Pilsen

RECRUITING

Fakultni nemocnice Bulovka, Prague

RECRUITING

Fakultni nemocnice Kralovske Vinohrady, Prague

RECRUITING

Fakultni Thomayerova nemocnice, Prague

RECRUITING

Institut klinicke a experimentalni mediciny, Prague

RECRUITING

Vseobecna fakultni nemocnice, Prague

RECRUITING

Masarykova nemocnice v Usti nad Labem, Ústí nad Labem

All Listed Sponsors
lead

Lipidica, a.s.

INDUSTRY