software Lipidica: The investigational in vitro diagnostic medical device-software (IVDSW) "Lipidica" processes and analyses data inputs from the analysis of lipid profile in human plasma using an in-house in vitro diagnostic medical device.
endoscopic ultrasonography: Endoscopic ultrasonography - maximum frequency: 3 times during the participation
magnetic resonance: Magnetic resonance - maximum frequency: 3 times during the participation
laboratory examination: Lipidomic analysis, CA 19-9, CEA, HbA1c and hCG levels assessment (hCG only in women of childbearing potential in Arm 2)
computed tomography: computed tomography - maximum frequency: 3 times during the participation
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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:
1. Family history of PaC (≥ 2 first-degree or second-degree relatives with PaC in the same family line)
2. Confirmed germline mutation of STK11 (LKB1) regardless of family history
3. Confirmed germline mutation of CDKN2A leading to the alteration of p16 regardless of family history
4. 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
5. Present hereditary pancreatitis (recurrent acute pancreatitis or chronic pancreatitis and confirmed germline mutation of PRSS1)
* Age:
1. 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)
2. Person with STK11 mutation: \> 35 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
3. Person with CDKN2A mutation: \> 40 years or 10 years before the diagnosis of PaC in the youngest family member (whichever comes first)
4. 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)
5. 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
Primary outcome measure(s)
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. — Interim analysis 1 year from first subject enrolled and through study completion (an average of 3 years) The primary objective will be assessed using the following parameters:
Diagnostic sensitivity The sensitivity is defined as the capacity to correctly detect confirmed positive samples of plasma from patient with PaC diagnosed with standard diagnostic methods.
Diagnostic specificity The specificity is the ability to correctly classify samples of plasma from patient without PaC but at higher risk of the disease. The diagnosis of PaC will be excluded using standard diagnostic methods.
Positive predictive value It is the ratio of patients with PaC truly diagnosed as positive to all those who had positive results (including healthy subjects who were incorrectly diagnosed as patients with PaC).
Negative predictive value It is the ratio of subjects truly diagnosed as negative to all those who had negative results (including patients with PaC who were incorrectly diagnosed as healthy).
Likelihood ratio and Expected values in normal and affected populations
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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