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New treatment option for Pancreas Cancer
Official title Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
ClinicalTrials.gov ID: NCT06549725
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Arm1:
- Age ≥ 18 years
- Signed informed consent
- Histologically confirmed diagnosis of resectable PaC
You likely can't join if
- Arm 1:
- History of any other cancer disease
- Present incurable malignancy
- Unfit for radical curative resection of the tumor
- Vegan or vegetarian diet Inclusion Criteria Arm2:
- Age ≥ 18 years
See the full eligibility criteria
- Arm1:
- Age ≥ 18 years
- Signed informed consent
- Histologically confirmed diagnosis of resectable PaC
- Arm 1:
- History of any other cancer disease
- Present incurable malignancy
- Unfit for radical curative resection of the tumor
- Vegan or vegetarian diet Inclusion Criteria Arm2:
- 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 Criteria Arm 2:
- Pregnancy of planning to conceive in the next 12 months
- History of any cancer disease
- Present incurable malignancy
- Inability to undergo planned medical imaging or blood sampling
- Vegan or vegetarian diet
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Czechia, Czechia
- Brno, Czechia
- České Budějovice, Czechia
- Hradec Králové, Czechia
- Jablonec nad Nisou, Czechia
- Olomouc, Czechia
- Pardubice, Czechia
- Pilsen, Czechia
- Prague, Czechia
- Ústí nad Labem, Czechia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prague, Czechia, Czechia; Brno, Czechia; České Budějovice, Czechia; Hradec Králové, Czechia; Jablonec nad Nisou, Czechia; Olomouc, Czechia and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.