Published: 14.11.2024
The pioneering research of Prof. Michal Holčapek and his team at the University of Pardubice is now being tested on patients in a clinical setting.
A clinical trial has begun in the Czech Republic to assess the effectiveness of an early detection test for pancreatic cancer. This trial will evaluate the sensitivity of a novel blood test designed to detect precancerous changes. If successful, this lipidomics-based test could revolutionise pancreatic cancer screening, offering a major advance in early diagnosis.
The trial is a collaborative effort between Lipidica – a company jointly owned by the University of Pardubice and FONS JK Group – and specialists in gastroenterology and oncology. Lipidica will perform sample analyses for the clinical study. Key partners include the University Hospital Olomouc and the Masaryk Memorial Cancer Institute, with a total of 15 centres nationwide expected to participate.
This methodology, which allows for early diagnosis, was developed by Prof. Michal Holčapek, a prominent analytical chemist and world-renowned expert in lipids at the University of Pardubice’s Faculty of Chemical Technology. Holčapek, a recipient of the prestigious European ERC Advanced grant, and his team achieved this breakthrough by analysing lipids in standard blood samples and applying advanced multivariate statistical analysis. "The lipidomics test is non-invasive and could pave the way for a structured screening programme,” explains Prof. Holčapek. "It may enable earlier detection of pancreatic cancer, where treatment success rates are higher and patient survival outcomes improve."
This innovative method has been published in Nature Communications, one of the world’s leading scientific journals, and is protected by two patents held by the University of Pardubice.
Experts from the Czech Gastroenterological Society (CGS) report that approximately 2 400 people are diagnosed with pancreatic cancer each year in the Czech Republic, and nearly 2 200 die from the disease within the same period. By 2030, experts project that pancreatic cancer will become the second leading cause of cancer deaths. "Pancreatic cancer is among the most aggressive forms of cancer – it develops asymptomatically over more than a decade but remains undetected until it is too advanced for effective treatment," says Prof. Ondřej Urban, M.D., Ph.D., Head of the Second Internal Gastroenterology and Geriatric Clinic at University Hospital Olomouc. "By the time symptoms appear, it is often too late for curative treatment, with surgery remaining the only potential cure, but only about 20% of patients qualify. The rest receive palliative care focused on extending life with as much quality as possible." For those with advanced pancreatic cancer, the average survival rate is about 1.5 years. However, patients diagnosed at an early stage can live up to six times longer. "We know that lipid profiles vary significantly in patients with pancreatic cancer," Prof. Urban adds. "This study aims to determine if the lipidomics test can detect these early lipid changes in high-risk individuals who feel healthy but may already have underlying disease."
According to doc. MUDr. Jan Trna, Ph.D., Chief Physician of the Gastroenterology Department at the Masaryk Memorial Cancer Institute, the successful validation of the new lipidomics test would represent a major breakthrough in pancreatic cancer treatment. "Currently, our options for identifying individuals at risk for pancreatic cancer are limited. Due to financial, capacity, and medical constraints, specialised preventive testing cannot be offered to everyone. However, blood sampling presents a different approach. For decades, we have sought methods to detect the disease early – which is absolutely critical for this particular cancer," says MUDr. Trna. The Pancreatic Cancer Early Detection Programme now enables the identification of precancerous changes or early-stage cancer. Under this programme, gastroenterologists collaborate closely with clinical geneticists and radiologists who conduct specialised tests such as magnetic resonance imaging (MRI).
Currently, the screening programme is available only to individuals with a lifetime risk of pancreatic cancer exceeding 5%. "In the newly established centres of highly specialised care for digestive endoscopy, including our department, at-risk individuals undergo regular pancreatic examinations using MRI and endoscopic ultrasonography," explains doc. MUDr. Ilja Tachecí, Ph.D., Chair of the CGS and Head of the Second Internal Gastroenterology Clinic at the Faculty of Medicine, Charles University in Hradec Králové. Individuals considered at risk include those with a hereditary form of chronic pancreatitis, those with two or more direct relatives diagnosed with pancreatic cancer, and carriers of specific genetic mutations – such as mutations in the BRCA1 and BRCA2 genes, which are also associated with breast and ovarian cancer.
"People at risk visit us for annual check-ups. As part of this study, we collect blood samples with their informed consent, which are then processed into plasma and sent to the Lipidica laboratory," explains Prof. Urban. The study thus analyses blood from both healthy high-risk individuals and patients with small, operable tumours. "Current diagnostic methods are highly effective but also costly and uncomfortable for patients. A test based on a simple blood draw would be a tremendous benefit for clinical practice. Our LDPC lipidomics test relies on a patent-protected methodology developed at the University of Pardubice, integrating insights from analytical chemistry, biostatistics, and other scientific disciplines," adds Ing. Karolína Kašparová, Director of Lipidica, which is also an accredited medical laboratory.
Lipidica, a.s., a joint venture between the University of Pardubice and FONS JK Group a.s., has been recognised with the Neuron Prize for its exceptional bridging of science and business.
The study began this year and is expected to conclude in 2027, involving over 400 participants. If the test's specificity and sensitivity are confirmed, experts note it may still take time before the test becomes a standard part of clinical care and before it is determined whether health insurers will cover it or if individuals will need to pay out of pocket. The manufacturer has indicated, however, that the price should not exceed a few thousand Czech korunas.
