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Clin Gastroenterol Hepatol. 2014 Oct;12(10):1717-23. doi: 10.1016/j.cgh.2014.02.038. Epub 2014 Mar 21.

A microRNA-based test improves endoscopic ultrasound-guided cytologic diagnosis of pancreatic cancer.

Author information

  • 1Department of Medicine, Division of Gastroenterology, Hepatology & Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
  • 2Asuragen, Inc, Austin, Texas.
  • 3Department of Pathology and Department of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
  • 4Center for Pancreatic Disease, Brigham and Women's Hospital, Boston, Massachusetts.
  • 5Department of Medicine, Division of Gastroenterology, University of Sherbrooke, Fleurimont, Quebec, Canada.
  • 6Department of Endoscopy, Hospital of the Ministry of Internal Affairs and Administration, Szczecin, Poland.
  • 7Department of Gastroenterology and Hepatology, Medical University of Silesia, Katowice, Poland.
  • 8Institute of Pathology, Ruhr-University of Bochum, Bochum, Germany.
  • 9Molecular GI-Oncology and Department of Pathology, Ruhr-University of Bochum, Bochum, Germany.
  • 10Department of Medicine, Division of Radiology, Medical University of Łódź, Łódz, Poland.
  • 11Department of Pathology and Department of Gasteroenterology and Hepatology, Dartmouth Hitchcock Medical Center and The Audrey and Theodor Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.
  • 12Asuragen, Inc, Austin, Texas. Electronic address:



Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in combination with cytopathology is the optimal method for diagnosis and staging of pancreatic ductal adenocarcinoma (PDAC) and other pancreatic lesions. Its clinical utility, however, can be limited by high rates of indeterminate or false-negative results. We aimed to develop and validate a microRNA (miRNA)-based test to improve preoperative detection of PDAC.


Levels of miRNAs were analyzed in a centralized clinical laboratory by relative quantitative polymerase chain reaction in 95 formalin-fixed paraffin-embedded specimens and 228 samples collected by EUS-FNA during routine evaluations of patients with solid pancreatic masses at 4 institutions in the United States, 1 in Canada, and 1 in Poland.


We developed a 5-miRNA expression classifier, consisting of MIR24, MIR130B, MIR135B, MIR148A, and MIR196, that could identify PDAC in well-characterized, formalin-fixed, paraffin-embedded specimens. Detection of PDAC in EUS-FNA samples increased from 78.8% by cytology analysis alone (95% confidence interval, 72.2%-84.5%) to 90.8% when combined with miRNA analysis (95% confidence interval, 85.6%-94.5%). The miRNA classifier correctly identified 22 additional true PDAC cases among 39 samples initially classified as benign, indeterminate, or nondiagnostic by cytology. Cytology and miRNA test results each were associated significantly with PDAC (P < .001), with positive predictive values greater than 99% (95% confidence interval, 96%-100%).


We developed and validated a 5-miRNA classifier that can accurately predict which preoperative pancreatic EUS-FNA specimens contain PDAC. This test might aid in the diagnosis of pancreatic cancer by reducing the number of FNAs without a definitive adenocarcinoma diagnosis, thereby reducing the number of repeat EUS-FNA procedures.

Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.


Cytologic Diagnosis; Fine-Needle Aspirate; MicroRNA; Pancreatic Cancer

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