Clinical trial · Interventional
Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Diseases | — | UNRESOLVED | — |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatitis, Chronic | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Procedure | — | UNRESOLVED |
| endoscopic ultrasonography | Procedure | — | UNRESOLVED |
| laboratory examination | Diagnostic Test | — | UNRESOLVED |
| magnetic resonance | Procedure | — | UNRESOLVED |
| software Lipidica | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Patients with Pancreatic cancer
- description
- Participants with histologically confirmed diagnosis of resectable Pancreatic cancer. Arm 1 will undertake one visit (baseline) for blood sampling - lipidomics, CA 19-9 and CEA, HbA1c. At baseline their participation ends.
- interventionNames
- Device: software Lipidica
- Diagnostic Test: laboratory examination
- type
- EXPERIMENTAL
- label
- Patient at risk of Pancreatic cancer
- description
- Participants without Pancreatic cancer but at higher risk of this cancer disease due to their predispositions. Arm 2 will come for two or three visits depending on results at baseline. On each visit blood sampling (lipidomics, CA 19-9 and CEA, HbA1c, hCG) and medical imaging by EUS, MR or CT will be performed. Their participation ends with the diagnosis of Pancreatic cancer or after 12 months of follow-up.
- interventionNames
- Device: software Lipidica
- Procedure: endoscopic ultrasonography
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available