NCT06549725

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 419 (estimated)
• Sponsor: Lipidica, a.s. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

Pancreatic cancer (PaC) is one of the cancer diseases with the worst prognosis, as mortality almost equals the incidence. In the Czech Republic, the incidence of pancreatic ductal adenocarcinoma (PDAC) has had a clear upward trend since the late 1970s, and in 2018, 21.9 new cases per 100,000 persons were reported. PDAC is associated with a poor prognosis for several reasons. Due to the usual asymptomatic course or occurrence of only non-specific symptoms, it is usually detected in an advanced stage. Moreover, the diagnosis by standard methods can be difficult in the early stages, and investigators lack sensitive and specific tumor markers. The disease forms distant metastases rapidly, which creates a very short time interval for effective curative interventions. So far, PaC screening possibilities in the Czech Republic are limited to several academic research screening cohorts. Five-year survival, regardless of clinical stage, is 7-9%. The resectable disease is detected in 10% of patients with a 5-year survival of 42%. Locally advanced unresectable disease is found in about 30% of patients with a 5-year survival of 12%, and metastatic disease is diagnosed in about 60% of patients with a 5-year survival of only approx. 3%. PaC screening is not suitable for an unselected population. By contrast, it is vital for individuals with a high risk of developing this disease due to family history and/or genetic predispositions. Early diagnosis resulted in more curative resections and longer survival in this population thanks to the screening programs. First economic evaluations described the possible cost-effectiveness of screening high-risk individuals. Changes in plasma lipid concentrations were reported in various cancer types (bladder, breast, colorectal, gastric, liver, kidney, lung, oesophageal, ovarian, prostate, thyroid, and pancreas). The altered plasma lipid profile may originate not only from tumor cells, tumor stroma, and apoptotic cells but also from an immune response. Previous study robustly proved a specific lipidomic phenotype in patients with PDAC across stages, age, treatments, or the presence of diabetes. Multiple lipid species were significantly downregulated in the plasma of PDAC patients, such as very long-chain monounsaturated sphingomyelins, ceramides and (lyso)phosphatidylcholines. The study showed that lipid profiling can discriminate between patients with PDAC and healthy controls or patients with pancreatitis. This clinical performance study (CPS) follows on from the previous study by Wolrab et al.

Conditions

• Pancreas Cancer
• Pancreatic Ductal Adenocarcinoma
• Hereditary Diseases
• Pancreatitis, Chronic

Interventions

Type	Name	Description
DEVICE	software Lipidica	The investigational in vitro diagnostic medical device-software (IVDSW) "Lipidica" processes and analyses data inputs from the analysis of lipid profile in human plasma using an in-house in vitro diagnostic medical device.
PROCEDURE	endoscopic ultrasonography	Endoscopic ultrasonography - maximum frequency: 3 times during the participation
PROCEDURE	magnetic resonance	Magnetic resonance - maximum frequency: 3 times during the participation
DIAGNOSTIC_TEST	laboratory examination	Lipidomic analysis, CA 19-9, CEA, HbA1c and hCG levels assessment (hCG only in women of childbearing potential in Arm 2)
PROCEDURE	computed tomography	computed tomography - maximum frequency: 3 times during the participation

Timeline

• Start date: 2024-09-10
• Primary completion: 2027-09-26
• Completion: 2027-09-26
• First posted: 2024-08-12
• Last updated: 2025-08-01

Locations

16 sites across 1 country: Czechia