Actively Recruiting
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
Eligibility Criteria
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)
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
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
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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