Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
Recruiting now · Not applicable
Conditions studied: Pancreas Cancer, Pancreatic Ductal Adenocarcinoma, Hereditary Diseases, Pancreatitis, Chronic
In brief
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 facts
- Study ID
- NCT06549725
- Run by
- Lipidica, a.s.
- People needed
- 419
- Starts
- 2024-09-10
- Expected to finish
- 2027-09-26
- Last updated by the study team
- 2026-04-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Masarykova nemocnice v Usti nad Labem — Ústí nad Labem, Czechia (enrolling)
- Fakultni nemocnice Brno — Brno, Czechia (enrolling)
- Fakultni nemocnice u sv. Anny — Brno, Czechia (enrolling)
- Masarykuv onkologicky ustav — Brno, Czechia (enrolling)
- Nemocnice Ceske Budejovice — České Budějovice, Czechia (enrolling)
- Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia (enrolling)
- Ustredni vojenska nemocnice — Prague, Czechia, Czechia (enrolling)
- Fakultni nemocnice Olomouc — Olomouc, Czechia (enrolling)
- Nemocnice Pardubickeho kraje — Pardubice, Czechia (enrolling)
- Fakultni nemocnice Plzen — Pilsen, Czechia (enrolling)
- Fakultni nemocnice Bulovka — Prague, Czechia (enrolling)
- Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia (enrolling)
- Fakultni Thomayerova nemocnice — Prague, Czechia (enrolling)
- Institut klinicke a experimentalni mediciny — Prague, Czechia (enrolling)
- Vseobecna fakultni nemocnice — Prague, Czechia (enrolling)
- Nemocnice Jablonec nad Nisou — Jablonec nad Nisou, Czechia
Full record on ClinicalTrials.gov
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