Trial Information

Detection of Pancreatic Cancer and Pre-cancer by Stool DNA Testing: A Feasibility Study

Pancreatic ductal adenocarcinoma (PDC) remains the fourth leading cause of cancer-related
death in the U.S. This is largely due to the fact that most patients present with advanced,
unresectable disease, highlighting the critical need for a screening test for this disease.
Stool testing is an approach that has not been explored for use in PDC screening. With the
advent of stool-based DNA tests, it may be possible to target genetic abnormalities that
have been recently characterized n PDC tumorigenesis.

Aim: The aim of this study is to determine if DNA alterations present in pancreatic cancer
and precancerous intrapapillary mucinous neoplasms (IPMN) can be reliably recovered in
matched stool.

Methods: This is a case-control prospective study to determine the utility of a stool-based
digital melt curve (DMC) assay in PDC screening. A total of 30 patients (18 with pancreatic
cancer, 12 with IPMN) who will be undergoing pancreatic resection will be enrolled.
Pancreatic neoplastic tissue will be isolated from their surgical specimens and the genes
most commonly mutated in PDC will be sequenced from extracted DNA. In addition,
hypermethylation at common promoter sites will be assessed by methylation-specific PCR. The
genetic and epigenetic alterations isolated in pancreatic tissue will be utilized as the
targets for stool DMC assay. Blinded technicians will process stool specimens from control
patients as well as a matched control. The primary outcomes of this study will be the
sensitivity and specificity of the stool DMC assay in detecting genetic mutations present in
tumor or IPMN lesions.