title: A Multicenter Trial Defining a Serum Protein Signature Associated with Pancreatic Ductal Adenocarcinoma.
abstract: Background. Pancreatic ductal adenocarcinoma (PDAC) is an aggressive disease with rapid tumor progression and poor prognosis. This study was motivated by the lack of sensitive and specific PDAC biomarkers and aimed to identify a diagnostic, serum protein signature for PDAC. Methods. To mimic a real life test situation, a multicenter trial comprising a serum sample cohort, including 338 patients with either PDAC or other pancreatic diseases (OPD) and controls with nonpancreatic conditions (NPC), was analyzed on 293-plex recombinant antibody microarrays targeting immunoregulatory and cancer-associated antigens. Results. Serum samples collected from different hospitals were analyzed and showed that (i) sampling from five different hospitals could not be identified as a preanalytical variable and (ii) a multiplexed biomarker signature could be identified, utilizing up to 10 serum markers that could discriminate PDAC from controls, with sensitivities and specificities in the 91-100% range. The first protein profiles associated with the location of the primary tumor in the pancreas could also be identified. Conclusions. The results demonstrate that robust enough serum signatures could be identified in a multicenter trial, potentially contributing to the development of a multiplexed biomarker immunoassay for improved PDAC diagnosis.
authors.affiliation: Department of Immunotechnology and CREATE Health, Lund University, Medicon Village 406, 223 81 Lund, Sweden.
authors.forename: Anna S
authors.initials: AS
authors.lastname: Gerdtsson
authors.affiliation: Genetic and Molecular Epidemiology Group, Spanish National Cancer Research Centre (CNIO), C/Melchor Fernández Almagro 3, 28029 Madrid, Spain.
authors.forename: Núria
authors.initials: N
authors.lastname: Malats
authors.affiliation: Department of Immunotechnology and CREATE Health, Lund University, Medicon Village 406, 223 81 Lund, Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Säll
authors.affiliation: Epithelial Carcinogenesis Group, Spanish National Cancer Research Centre (CNIO), C/Melchor Fernández Almagro 3, 28029 Madrid, Spain ; Department of Experimental and Health Sciences, University of Pompeu Fabra, Dr. Aiguader 88, 08003 Barcelona, Spain.
authors.forename: Francisco X
authors.initials: FX
authors.lastname: Real
authors.affiliation: Hospital del Mar Medical Research Institute (IMIM), CIBERESP, UAB, Dr. Aiguader 88, 08003 Barcelona, Spain.
authors.forename: Miquel
authors.initials: M
authors.lastname: Porta
authors.affiliation: Department of Immunotechnology and CREATE Health, Lund University, Medicon Village 406, 223 81 Lund, Sweden.
authors.forename: Petter
authors.initials: P
authors.lastname: Skoog
authors.affiliation: Department of Immunotechnology and CREATE Health, Lund University, Medicon Village 406, 223 81 Lund, Sweden.
authors.forename: Helena
authors.initials: H
authors.lastname: Persson
authors.affiliation: Department of Immunotechnology and CREATE Health, Lund University, Medicon Village 406, 223 81 Lund, Sweden.
authors.forename: Christer
authors.initials: C
authors.lastname: Wingren
authors.affiliation: Department of Immunotechnology and CREATE Health, Lund University, Medicon Village 406, 223 81 Lund, Sweden.
authors.forename: Carl A K
authors.initials: CA
authors.lastname: Borrebaeck