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

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

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

Conditions5

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