title: Neue diagnostische Verfahren beim Pankreaskarzinom
Creators: name: Verfaillie, Daniela
Publisher: name: Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
Year: 2024

description: 2. Abstract 2.1 Objectives The ductal adenocarcinoma of the pancreas (PDAC) is one of the most lethal cancer diseases. Until 2025 the death rate in Europe of the patients with PDAC are going to increase about 50% in comparison to 2010. The main reason therefore is that most of the patients present first symptoms at an advanced stage of the disease, where there is no possible cure anymore. Hence there are no early, alarming symptoms for patients with PDAC. The challenge of the future will be to establish a reliable blood test for early detection of PDAC. The primary aim of this study was to verify the accuracy of the panel IMMrayTM PanCan-d test in detection of PDAC developed by Immunovia. The IMMrayTM is an antibody-based microarray technology that measures the proteins in serum. Thus antibody microarray slides are printed and incubated with biotinylated patient serum. Finally, levels of bound antigens will be detected by fluorescence scanning. 2.2 Design and Methods This was a prospective clinical study at a tertiary referral center in the university hospital of Erlangen, Germany. Blood samples from 100 PDACs were collected as well as 193 controls. All blood samples were from patients with newly discovered pathological pancreatic lesions and hence not treated before by radio-, chemotherapy or surgery. All PDACs were histologically confirmed. The control group were patients with chronic pancreatitis, intraductal papillary mucinous neoplasm (IPMN), neuroendocrine tumors and patients with bile duct tumors. In the end a biomarker test panel called IMMrayTM PanCan-d was evaluated by Immunovia in a maschine learning setting on its accuracy for detection of PDAC in this selected group of patients. The primary endpoint was to analyze the sensitivity and specifity for IMMrayTM PanCan-d for detection of PDAC in the Erlanger patient group. 2.3 Observations and Results Two patient cohorts, one with 40 histologically confirmed early stage PDAC and one with 193 non-PDAC were used to validate a biomarker signature for detection of adenocarcinoma of the pancreas. The IMMrayTM Pan Can- 8 plex signature is together with CA 19-9 able to differentiate PDAC from symptomatic non-PDACs patients. The data from the Erlanger patients are showing following results: 4 1. The accuracy of differentiating PDAC (I- IV) from healthy controls is about 99,5%. 2. The accuracy of diagnosing PDAC via blood sample is about 72,5%. The area under the curve is 0,935. In our group of patients (n=40), we could show that in early PDAC stages, there is a significant increase of bilirubin (&gt;1,2mg/dl) as well as leukozytes (4,000 – 10,000 cells/μl) in the serum blood. 2.4 Conclusions The study is showing that a serum biomarker signature can be used for diagnosing early-stage pancreatic cancer. Together with the tumormarker CA19-9 it can even give more accurate results. Currently imaging is the gold standard for patients with suspicious symptoms for malign pancreatic lesons. But as the incidence of PDAC in the general population is very low, general screening with imaging is not applicable. A new tool for screening and monitoring patients at a high risk for PDAC could be a reliable blood test. In the near future the IMMrayTM Pan-Can-d test could ensure to diagnose patients in an early stage of the disease and therefore enable to treat significantly more patients. Before the blood test can be used on a regular basis, larger comparative studies need to be performed.