The detection of CC remains a diagnostic challenge, particularly in patients with primary sclerosing cholangitis (PSC), a chronic cholestatic liver disease characterized by progressive inflammation and fibrosis of the bile ducts. These patients develop CC in approximately 30% of all cases during the first 10 years of the disease. A major clinical challenge is the discrimination of CC from benign bile duct strictures, even more considering that CC may develop quite early in the disease course. One approach to improve life-saving curative treatment (e.g. surgical liver resection or orthotopic liver transplantation), is to enable early detection of CC with high accuracy.
The protexam BPA-CC (Bile Proteome Analysis-CC) and UPA-CC (Urine Proteome Analysis-CC) tests are established diagnostic tests based on biomarkers in bile and urine. The tests can detect both local and systematic changes during CC progression. The tests show that combined bile and urine analysis demonstrated accuracy for CC detection of 92% and a negative predictive value of 96%.
The protexam BPA-CC and UPA-CC tests can be used to complement invasive endoscopic retrograde cholangiopancreatography (ERCP). The tests also enable a more precise diagnosis in the case of an unclear suspicion of CC.
What is the added value with the protexam BPA-CC and UPA-CC tests?
Eurotransplant also sees an urgent need for improved CC detection in PSC.
We proved the evidence and high analytical accuracy in a clinical study together with the Medical School Hannover. Bile samples were collected at the gastrointestinal endoscopy unit. This work was supported by the “Niedersächsische Krebsgesellschaft” and a grant from the German Federal Ministry of Education and Research (reference number: 01EO0802).
With the new tests, CC can also be diagnosed if the bile ducts have become chronically inflamed and have changed. It will become a diagnostic tool of the future. This would be a milestone on the way to more efficient treatment for various bile duct diseases.
For non-invasive follow-up: protexam UPA-CC test.
Patients with chronic inflammation of the bile ducts, which gradually leads to an obstruction of the bile ducts, have a greatly increased risk of developing CC. The protexam UPA-CC test is particularly suitable for regular, non-invasive monitoring of patients with inflammation of the bile ducts. Because only if a tumor of the bile ducts is detected at an early stage, it is possible to perform a life-saving surgical removal.
References:
https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.24103
https://gut.bmj.com/content/62/1/122
https://onlinelibrary.wiley.com/doi/10.1177/2050640616687836
https://jbiomedsci.biomedcentral.com/articles/10.1186/s12929-019-0599-5
Proteomics, a sector of biochemistry, depicts the entire set of proteins in the body. Proteins are the functional molecules of a cell and demonstrate the basis of life. The proteome is dynamic and is changing over time (other than genomics which is always constant), and therefore represent always the actual state of the body ("snapshot").
Clinical proteomics enables the analysis from basic research to clinical trials, considering the clinical needs.
For clinical proteomics the mosaiques group has developed recommendations that became meanwhile industry standards. Today, the technology can be successfully used for clinical diagnostics, as well as identification of therapeutic targets.
Why is proteomics the key to modern medicine?
Diseases are not associated with one protein, but with several proteins and their respective expression. A quantitative and qualitative evaluation of the proteins is necessary for gaining knowledge.
Diseases arise at the molecular level (= proteins) of the body. At this level, the biochemical processes of a disease development and control takes place. This diagnostic level remains closed to other ‘omics technologies and can only be accessed by proteomics.
Clinical proteomics - the game changer to modern medicine?
With clinical proteomics diseases can be detected at an early stage of their development.
Furthermore, the prognoses of the disease progression and the general susceptibility of the human body to diseases can be mapped. That is made possible by the direct association with pathophysiology of diseases.
The mosaiques group has invented and developed clinical proteomics through the combination of capillary electrophoresis coupled to mass spectrometry. The basis for the successful use of clinical proteome analysis at mosaiques was the generation of proprietary software tools for the handling of big data.
The gained big data from all measurements combined together with clinical data are stored in the mosaiques database
Today, our technology can be successfully used for clinical diagnostics and biomarker identification.