RecruitingNot Applicable

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

Czechia419 participantsStarted 2024-09-10

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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)
✕. 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)

What they're measuring

The primary objective is to verify that the investigational IVDSW can discriminate between results of patients with PaC and persons without PaC but at higher risk of this cancer disease due to their predispositions.

Timeframe: Interim analysis 1 year from first subject enrolled and through study completion (an average of 3 years)

Trial details

NCT IDNCT06549725

SponsorLipidica, a.s.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-26

Contact for this trial

Karolina Kasparova

+420723 242 544 karolina.kasparova@lipidica.cz

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