RecruitingNot ApplicableNCT06549725

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


Sponsor

Lipidica, a.s.

Enrollment

419 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing software called "Lipidica 1.0" that analyzes fat molecule (lipid) patterns in blood to help detect or screen for pancreatic cancer. The study includes both patients who already have diagnosed pancreatic cancer and people at high genetic risk of developing it. The goal is to see if this tool can identify pancreatic cancer earlier than current methods. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with surgically removable pancreatic cancer (Arm 1), OR - You are at high risk of pancreatic cancer due to a family history (2+ relatives with pancreatic cancer) or a confirmed genetic mutation such as BRCA2, CDKN2A, STK11, ATM, or others (Arm 2) **You may NOT be eligible if...** - You have had any other cancer - You have an incurable malignancy - You are not eligible for surgery (Arm 1) - You follow a vegan or vegetarian diet - You do not meet the genetic or family history criteria for high-risk screening (Arm 2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEsoftware 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.

PROCEDUREendoscopic ultrasonography

Endoscopic ultrasonography - maximum frequency: 3 times during the participation

PROCEDUREmagnetic resonance

Magnetic resonance - maximum frequency: 3 times during the participation

DIAGNOSTIC_TESTlaboratory examination

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

PROCEDUREcomputed 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

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NCT06549725


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