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

Autor: Siegfried Kropf, Yue Zhao, Christiane J. Bruns, Felix Popp, Christoph Benckert, Hans Lippert, Thomas Kalinski, Christopher Betzler, Benjamin Garlipp, Marie Christine Popp
Jazyk: angličtina
Předmět:
0301 basic medicine
Oncology
medicine.medical_specialty
Receptors
CXCR4
Cancer Research
Personalized therapy
Prediction of outcome
lcsh:RC254-282
Pancreatic ductal adenocarcinoma
03 medical and health sciences
Study Protocol
0302 clinical medicine
Surgical oncology
Internal medicine
Pancreatic cancer
medicine
Biomarkers
Tumor
Genetics
Humans
Biomarker Analysis
Prospective Studies
Prospective cohort study
Biomarker analysis
Smad4 Protein
business.industry
Prognosis of pancreatic cancer
outcome
Intracellular Signaling Peptides and Proteins
Cancer
SOX9 Transcription Factor
medicine.disease
Clinical test development
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Immunohistochemistry
Clinical trial
Pancreatic Neoplasms
030104 developmental biology
Rt.-PCR
030220 oncology & carcinogenesis
Adenocarcinoma
Biomarker (medicine)
Surgery
Pattern of recurrence
business
Zdroj: BMC Cancer, Vol 17, Iss 1, Pp 1-9 (2017)
BMC Cancer
ISSN: 1471-2407
DOI: 10.1186/s12885-017-3186-8
Popis: Pancreatic 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. Patients 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. Pancreatic 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. German Clinical Trials Register, DRKS00006179 .
Databáze: OpenAIRE
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