Software that reads blood fat tests to screen high-risk people for pancreatic cancer
Tests software that reads blood fat results to screen high-risk adults for pancreas cancer.
Plain-language title generated from the registry record
Registry title: Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
Key facts
- Where
- Brno, České Budějovice, Hradec Králové, Jablonec nad Nisou, Olomouc, Pardubice, Pilsen, Prague, and Ústí nad Labem, CzechiaSee the 16 sites
Where in Czechia
- Fakultni nemocnice BrnoBrno, CzechiaTaking people
- Fakultni nemocnice u sv. AnnyBrno, CzechiaTaking people
- Masarykuv onkologicky ustavBrno, CzechiaTaking people
- Nemocnice Ceske BudejoviceČeské Budějovice, CzechiaTaking people
- Fakultni nemocnice Hradec KraloveHradec Králové, CzechiaTaking people
- Nemocnice Jablonec nad NisouJablonec nad Nisou, CzechiaNot yet recruiting
- Fakultni nemocnice OlomoucOlomouc, CzechiaTaking people
- Nemocnice Pardubickeho krajePardubice, CzechiaTaking people
- Fakultni nemocnice PlzenPilsen, CzechiaTaking people
- Fakultni nemocnice BulovkaPrague, CzechiaTaking people
- Fakultni nemocnice Kralovske VinohradyPrague, CzechiaTaking people
- Fakultni Thomayerova nemocnicePrague, CzechiaTaking people
- Institut klinicke a experimentalni medicinyPrague, CzechiaTaking people
- Ustredni vojenska nemocnicePrague, CzechiaTaking people
- Vseobecna Fakultni NemocnicePrague, CzechiaTaking people
- Masarykova nemocnice v Usti nad LabemÚstí nad Labem, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lipidica, a.s.
- Trial code
- NCT06549725
- Record updated
- 27 April 2026
- Original description
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.Read full original descriptionShow less
Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
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
Inclusion: Age ≥ 18 years; Signed informed consent; Histologically confirmed diagnosis of resectable PaC; Age ≥ 18 years; Signed informed consent; High risk of PaC due to the presence of one of the following risk factors:; Family history of PaC (≥ 2 first-degree or second-degree relatives with PaC in the same family line); Confirmed germline mutation of STK11 (LKB1) regardless of family history; Confirmed germline mutation of CDKN2A leading to the alteration of p16 regardless of family history; Confirmed germline mutation of APC, ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2 or TP53 AND ≥ 1 first-degree or second-degree relative with PaC; Present hereditary pancreatitis (recurrent acute pancreatitis or chronic pancreatitis and confirmed germline mutation of PRSS1); Age:; Person with a family history of PaC: > 50 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first); Person with STK11 mutation: > 35 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first); Person with CDKN2A mutation: > 40 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first); Person with APC, ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2 or TP53 mutation: > 45 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first); Person with hereditary pancreatitis: > 40 years or 20 years after the 1st attack (whichever comes first).
Exclusion: Unfit for radical curative resection of the tumor; History of any other cancer disease; Present incurable malignancy; History of any cancer disease; Present incurable malignancy; Vegan or vegetarian diet; Pregnancy of planning to conceive in the next 12 months; Inability to undergo planned medical imaging or blood sampling; Vegan or vegetarian diet.