Using Lipidica software to screen for pancreatic cancer in high-risk patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the performance of the Lipidica software, designed to process lipidomic data for screening pancreatic cancer in individuals at high risk due to genetic factors or family history. Participants will undergo blood sampling and medical imaging to assess the software's ability to distinguish between patients with pancreatic cancer and those without. The study aims to improve early detection of pancreatic cancer, which is often diagnosed at advanced stages due to non-specific symptoms and lack of sensitive markers. By focusing on high-risk populations, the study seeks to enhance screening methods and potentially improve patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Ustredni vojenska nemocnice
  Prague, Czechia, Czechia Recruiting
• Fakultni nemocnice Brno
  Brno, Czechia Recruiting
• Fakultni nemocnice u sv. Anny
  Brno, Czechia Recruiting
• Masarykuv onkologicky ustav
  Brno, Czechia Recruiting
• Nemocnice Ceske Budejovice
  České Budějovice, Czechia Recruiting
• Fakultni nemocnice Hradec Kralove
  Hradec Králové, Czechia Recruiting

Study contacts

• Study coordinator: Karolina Kasparova
• Email: karolina.kasparova@lipidica.cz
• Phone: +420723 242 544

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.