Lipidica, a.s. is preparing a clinical performance study to verify the accuracy of the LDPC test and compliance to the IVDR (The In Vitro Diagnostic Medical Devices Regulation) with the title “Clinical performance of medical device software “Lipidica 1.0” for processing data generated by lipidomic analysis (LDPC) in pancreatic cancer screening”. This study has to be approved by the national regulatory authority State Institute for Drug Control and Ethics Committees. Subsequently it will be possible to take part in the study if you have been newly diagnosed with pancreatic cancer (PDAC), or if you are in a so-called high-risk group.
Only after the successful completion of this study, it will be possible to use the LDPC test in clinical practice to monitor people at risk.
You can check your risk of pancreatic cancer using our questionnaire.
Clinical validation of the test
The clinical validation of the LDPC (Lipidomic Diagnostics of Pancreatic Cancer) test aims to independently determine the sensitivity and specificity of this test. This means analysing a sufficiently large set of samples, some of which come from patients with early-stage disease (cohort 1) and some from healthy patients who are at increased risk of developing this cancer (cohort 2).
The percentage of samples that are falsely identified as negative defines the sensitivity of the test. The percentage of samples that are falsely identified as positive defines the specificity of the test.
Lipidica will conduct a study to evaluate the clinical function of the LDPC test in collaboration with the CZECRIN research infrastructure, which operates at the Masaryk University, Faculty of Medicine and in selected healthcare facilities. Key partners are the Masaryk Memorial Cancer Institute and the University Hospital Olomouc, where a pilot screening of pancreatic cancer in high-risk individuals in the SCREPAN and HEPACAS studies is being conducted at these sites in the Czech Republic. These healthcare facilities will be responsible for communicating with participants and those interested in participating in the study and will also be responsible for study procedures according to the study protocol, including the blood collection. The anonymized (blinded) samples will be transported to the Lipidica laboratory, which will perform the LDPC lipidomic test. The results will be sent to a secure data repository and continuously evaluated with respect to the study objectives of assessing clinical function and determining sensitivity and specificity.
List of healthcare facilities recruiting eligible individuals for the study:
To be added after after approval by the Ethics Committees.
Clinical trial participants
For a statistically conclusive validation of the method, approx. 400 study participants will need to be recruited from the following groups, predominantly from the at-risk group:
- Newly diagnosed PDAC patients older than 18 years with stage 1 and 2 tumors (approximately 10% of newly diagnosed patients in the Czech Republic).e 1 and 2 tumours (approximately 10% of newly diagnosed patients in the Czech Republic).
- Individuals at increased risk of developing pancreatic cancer (> 5%) (see Pancreatic cancer).
You can check your risk of pancreatic cancer using our questionnaire.