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

Launched by LIPIDICA, A.S. · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new software called "Lipidica," which is designed to analyze data from a special blood test that looks for signs of pancreatic cancer. The goal is to see if this software can help identify patients who have pancreatic cancer compared to those who are at high risk of developing it but do not currently have the disease. This could be especially important for people with a family history of pancreatic cancer or certain genetic mutations that increase their risk.

To participate in this trial, you must be at least 18 years old and give your consent. There are two groups in the study: one includes patients who have been diagnosed with operable pancreatic cancer, and the other includes individuals with a high risk of developing the disease due to family history or specific genetic mutations. Participants will need to visit the clinic for blood tests and medical imaging at the beginning and end of the study, and some may need an additional visit based on their initial results. It's important to note that certain individuals, such as those with a history of other cancers or those on vegetarian or vegan diets, may not be eligible to participate.

Gender

ALL

Eligibility criteria

• 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