Status:
RECRUITING
Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
Lead Sponsor:
Lipidica, a.s.
Conditions:
Pancreas Cancer
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) i...
Detailed Description
Pancreatic cancer (PaC) is one of the cancer diseases with the worst prognosis, as mortality almost equals the incidence. In the Czech Republic, the incidence of pancreatic ductal adenocarcinoma (PDAC...
Eligibility Criteria
Inclusion
- Inclusion Criteria Arm1:
- Age ≥ 18 years
- Signed informed consent
- Histologically confirmed diagnosis of resectable PaC
- Exclusion Criteria 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
Exclusion
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 26 2027
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT06549725
Start Date
September 10 2024
End Date
September 26 2027
Last Update
August 1 2025
Active Locations (16)
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1
Ustredni vojenska nemocnice
Prague, Czechia, Czechia
2
Fakultni nemocnice Brno
Brno, Czechia
3
Fakultni nemocnice u sv. Anny
Brno, Czechia
4
Masarykuv onkologicky ustav
Brno, Czechia