Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06549725

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

Led by Lipidica, a.s. · Updated on 2026-04-27

419

Participants Needed

16

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Signed informed consent
  • Histologically confirmed diagnosis of resectable pancreatic cancer (Arm 1)
  • High risk of pancreatic cancer due to family history, specific gene mutations, or hereditary pancreatitis (Arm 2)
  • Age criteria based on risk factors: over 50 years with family history, over 35 years with STK11 mutation, over 40 years with CDKN2A mutation, over 45 years with other listed mutations, or over 40 years or 20 years after first pancreatitis attack for hereditary pancreatitis (Arm 2)
Not Eligible

You will not qualify if you...

  • History of any other cancer disease
  • Present incurable malignancy
  • Unfit for radical curative tumor resection (Arm 1)
  • Vegan or vegetarian diet
  • Pregnancy or planning to conceive in next 12 months (Arm 2)
  • Inability to undergo planned medical imaging or blood sampling (Arm 2)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Ustredni vojenska nemocnice

Prague, Czechia, Czechia

Actively Recruiting

2

Fakultni nemocnice Brno

Brno, Czechia

Actively Recruiting

3

Fakultni nemocnice u sv. Anny

Brno, Czechia

Actively Recruiting

4

Masarykuv onkologicky ustav

Brno, Czechia

Actively Recruiting

5

Nemocnice Ceske Budejovice

České Budějovice, Czechia

Actively Recruiting

6

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Actively Recruiting

7

Nemocnice Jablonec nad Nisou

Jablonec nad Nisou, Czechia

Not Yet Recruiting

8

Fakultni nemocnice Olomouc

Olomouc, Czechia

Actively Recruiting

9

Nemocnice Pardubickeho kraje

Pardubice, Czechia

Actively Recruiting

10

Fakultni nemocnice Plzen

Pilsen, Czechia

Actively Recruiting

11

Fakultni nemocnice Bulovka

Prague, Czechia

Actively Recruiting

12

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Actively Recruiting

13

Fakultni Thomayerova nemocnice

Prague, Czechia

Actively Recruiting

14

Institut klinicke a experimentalni mediciny

Prague, Czechia

Actively Recruiting

15

Vseobecna fakultni nemocnice

Prague, Czechia

Actively Recruiting

16

Masarykova nemocnice v Usti nad Labem

Ústí nad Labem, Czechia

Actively Recruiting

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Research Team

K

Karolina Kasparova

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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