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

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

This study is testing a new software called Lipidica to see if it can help find pancreatic cancer earlier in people who are at high risk because of their genetics or family history.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 419 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lipidica, a.s. (industry)
• Locations: 16 sites (Prague, Czechia and 15 other locations)
• Trial ID: NCT06549725 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 and older with a family history of pancreatic cancer or specific genetic mutations that increase their risk.

Not a fit: Patients with a history of other cancers or those who are not fit for radical curative resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection of pancreatic cancer, improving treatment options and survival rates for high-risk patients.

How similar studies have performed: While there have been limited screening options for pancreatic cancer, this approach using lipidomic analysis is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Prague, Czechia and 15 other locations

• 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)
• Nemocnice Jablonec nad Nisou — Jablonec nad Nisou, Czechia (NOT_YET_RECRUITING)
• Fakultni nemocnice Olomouc — Olomouc, Czechia (RECRUITING)
• Nemocnice Pardubickeho kraje — Pardubice, Czechia (RECRUITING)
• Fakultni nemocnice Plzen — Pilsen, Czechia (RECRUITING)
• Fakultni nemocnice Bulovka — Prague, Czechia (RECRUITING)
• Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia (RECRUITING)
• Fakultni Thomayerova nemocnice — Prague, Czechia (RECRUITING)
• Institut klinicke a experimentalni mediciny — Prague, Czechia (RECRUITING)
• Vseobecna fakultni nemocnice — Prague, Czechia (RECRUITING)
• Masarykova nemocnice v Usti nad Labem — Ústí nad Labem, Czechia (RECRUITING)

Study contacts

• Study coordinator: Karolina Kasparova

Conditions: Pancreas Cancer, Pancreatic Ductal Adenocarcinoma, Hereditary Diseases, Pancreatitis, Chronic