Development of Chronic Pancreatitis Biomarkers

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DESCRIPTION (provided by applicant): Chronic pancreatitis, a destructive disease of the pancreas, is difficult to diagnosis and can present with a variety of symptoms. The incidence of chronic pancreatitis is not known; hospital admission and discharge summaries suggest at least 60,000 patients in the US per year, however these are under-estimates and it is clear that many patients have occult disease. The financial burden of pancreatitis to society is substantial: with loss of work and health care costs, the burden approaches $2.5 billion annually. There are currently no good bloods tests for the diagnosis of chronic pancreatitis; endoscopic studies and CT scan are the standard approaches for the diagnosis, with endoscopic ultrasound (EUS) combined with pancreatic function tests (PFT) being the most sensitive. We propose a carefully constructed algorithm for the development of biomarkers for chronic pancreatitis. Our technology for candidate biomarkers discovery uses state-of-the- art proteomics. Our group has an excellent experience working together and each member is considered an expert in their applied field. The preliminary data reveals that we can detect the proteins that underlie pancreatitis and we provide proof of principle that the proteins discovered in tissue are measurable in the blood by ELISA. The feasibility of the proposal is further supported by the fact that we have recruited more than one third of the patients required for the study, we demonstrate that the ITRAQ proteomics techniques are robust and accurate, and that there appears to be no problem with heterogeneity in the pancreatitis proteome based on differences in the gender or ethnic origin of the patient. Our preliminary results support our thesis of protein discovery leading to a measurable biomarker for pancreatitis and also demonstrate the ability of the team to work effectively and successfully. The cohort in which the biomarkers will be developed are highly defined and represent the clinical setting in which the biomarker would be used. The initial biomarker studies look promising. An accurate biomarker for chronic pancreatitis would be of enormous clinical benefit and could save time and costs in comparison to the current gold standard of endoscopic testing for the disease.