Protocol of the PANCALYZE trial: a multicenter, prospective study investigating the tumor biomarkers CXCR4, SMAD4, SOX9 and IFIT3 in patients with resected pancreatic adenocarcinoma to predict the pattern of recurrence of the disease

BMC Cancer

Study Protocol

Benjamin Garlipp¹  Christoph Benckert²  Yue Zhao³  Marie Christine Popp³  Christopher Betzler³  Christiane J. Bruns³  Felix C. Popp³  Thomas Kalinski⁴  Siegfried Kropf⁵  Hans Lippert⁶ 

[1] Clinic for General, Visceral and Vascular Surgery, University Clinic Magdeburg, Magdeburg, Germany;Department of General and Visceral Surgery, Vivantes Klinikum im Friedrichshain, Berlin, Germany;Department of General, Visceral and Cancer Surgery, University of Cologne, Cologne, Germany;Department of Pathology, Otto von Guericke University, Magdeburg, Germany;Institute for Biometrics and Medical Informatics, Otto-von-Guericke University, Magdeburg, Germany;Institute for Quality Control in Operative Medicine, Otto von Guericke University, Magdeburg, Germany;

关键词: Biomarker analysis;    Pancreatic ductal adenocarcinoma;    Clinical test development;    Prediction of outcome;    Personalized therapy;    Surgery;    Pattern of recurrence;    Prognosis of pancreatic cancer, outcome;    Immunohistochemistry;    Rt.-PCR;   

DOI  :  10.1186/s12885-017-3186-8

 received in 2015-08-29, accepted in 2017-03-09,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundPancreatic ductal adenocarcinoma (PDAC) is one of the most lethal malignancies today with an urgent need for novel therapeutic strategies. Biomarker analysis helps to better understand tumor biology and might emerge as a tool to develop personalized therapies. The aim of the study is to investigate four promising biomarkers to predict the clinical course and particularly the pattern of tumor recurrence after surgical resection.DesignPatients undergoing surgery for PDAC can be enrolled into the PANCALYZE trial. Biomarker expression of CXCR4, SMAD4, SOX9 and IFIT3 will be prospectively assessed by immunohistochemistry and verified by rt.-PCR from tumor and adjacent healthy pancreatic tissue of surgical specimen. Immunohistochemistry expression pattern of all four biomarkers will be combined into a single score. Beginning with the hospital stay clinical data from enrolled patients will be collected and followed. Different adjuvant chemotherapy protocols will be used to create subgroups. The combined biomarker expression score will be correlated with the further clinical course of the patients to test the hypothesis if CXCR4 positive, SMAD4 negative, SOX9 positive, IFIT3 positive tumors will predominantly develop metastatic spread.DiscussionPancreatic cancer is associated with different patterns of progression requiring personalized therapeutic strategies. Biomarker expression analysis might be a tool to predict the pattern of tumor recurrence and discriminate patients that develop systemic metastatic disease from those with tumors that rather develop local recurrence over time. This data might lead to personalized adjuvant treatment decisions as patients with tumors that stay localized might benefit from adjuvant local therapies like radiochemotherapy as compared to those with systemic recurrence who would benefit exclusively from chemotherapy.Moreover, the pattern of propagation might be a predefined characteristic of pancreatic cancer determined by the genetic signature of the tumor. In the future, biomarker expression analysis could be performed on tumor biopsies to develop personalized therapeutic pathways right after diagnosis of cancer.Trial registrationGerman Clinical Trials Register, DRKS00006179.

【 授权许可】

CC BY   
© The Author(s). 2017