Optical and Biochemical Biomarkers in Early Pancreatic Cancer

Pancreatic juice collection is performed by intravenous injection of FDA approved synthetic
human secretin (ChiRhoClin Inc., Burtonsville, MD) at a dose of 0.2 µg/kg will be
administered while the endoscope is positioned in the second portion of the duodenum. From
within the duodenum and without cannulation of the papilla of Vater, a 2.3-mm plastic
aspiration catheter (Olympus, Tokyo, Japan) will be passed through the biopsy channel of the
endoscope until visible on screen in the endoscopic monitor. Once active visible secretion
via the papilla has begun, the first 10 ml of pancreatic juice will be collected via
suctioning. This entire process from secretin injection to sample collection takes an average
of 5 minutes. The sample is then aliquoted into 2 ml ampules, which are snap-frozen in liquid
nitrogen (or portable rapid-freeze freezer) and freezer-stored until the assays are
performed. The top 10 candidate markers from discovery and validation on tissue (AUCs >0.95)
and from pilot pancreatic-juice testing (AUCs >0.9) will be evaluated in this study.
Following extraction from an equivalent of 0.4 ml pancreatic juice, DNA will be bisulfite
treated using optimized methods. Then, an assay of aberrant methylation on target genes will
be conducted using the QuARTS technique. Results will be normalized to either a human DNA
marker (eg, beta-actin) or a methylated DNA marker identified for normal pancreatic
epithelium.

Inclusion Criteria:

- Patients who are referred for the evaluation of pancreas cancer, pancreatic cystic
neoplasm, and family history of pancreas cancer.

- International normalized ratio (INR) less than 1.5

- Platelet count >50,000

Exclusion Criteria:

- Any medical condition that preclude the patient from having a therapeutic procedure
regardless of the Endoscopic ultrasound (EUS) finding

- Pregnant patients