CLINICAL PERFORMANCE STUDY LIPIDICA_01-2024
Pancreatic cancer is the 10th most common type of cancer. In 2022, more than 2,400 new cases were diagnosed in the Czech Republic.
Approximately 2,100 patients succumb to this disease, which is more than 87%. The main reason for the high percentage of deaths is the late diagnosis of this cancer, therefore Lipidica, a.s. is preparing the implementation of a study of the functional suitability of the lipidomic test LDPC called “Study of the clinical function of the medical device-software “Lipidica 1.0″ processing data from lipidomic analysis (LDPC) for pancreatic cancer screening”.
The aim of the study is to independently determine the sensitivity and specificity of the test.
RECRUITMENT OF PATIENTS
Approximately 400 participants will be assigned to the following groups:
Persons with newly diagnosed PDAC – patients over 18 years of age with stage 1 and 2 tumours (approximately 10% of newly diagnosed patients in the Czech Republic)
People at increased risk of developing pancreatic cancer (> 5%)
The study is being conducted in collaboration with CZECRIN, Masaryk Cancer Institute and 14 other large hospitals in the Czech Republic.
The study documentation is currently being reviewed by the ethics committees of the hospitals involved and the regulatory authority. If the study is successfully completed, the test can be used in clinical practice to monitor people at risk.
Important links to the project
Contact
Project Manager:
Ing. Karolína Grodová | karolina.grodova@med.muni.cz
info@lipidica.cz