Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Pancreatic Cancer

This clinical testing protocol outlines the validation process for an epigenetic assay targeting host peripheral blood cell and the associated host DNA methylation signatures designed to diagnose pancreatic cancer. The overall protocol process will involve three distinct stages representing three patient cohorts with up to 150 subjects per cohort across 3 populations of patients. Cohort one will act as signature development phase; cohort two will act as signature finalization phase; and cohort three will act as a validation cohort phase. Each cohort with include the following patient populations with up to 50 patients per population:

• Pancreatic cancer, NO chemotherapy. Surgical resection and/or radiation therapy
• Pancreatic cancer, WITH chemotherapy. All stages including remission
• At risk group (individuals who have chronic pancreatitis, been diagnosed with an intraductal papillary mucinous neoplasm (IPMN), have a family history of pancreatic cancer and/or have a known genetic disposition)

Inclusion criteria

• 18 years old or older
• Patient of UMMS
• Willing and able to consent to study procedures listed in the protocol
• Ability to speak and understand English
• Has a history of pancreatic cancer of is at high risk for pancreatic cancer

Exclusion criteria

• Younger than 18 years old
• Patient not cared for at UMMS
• Unable to consent to study procedures listed in the protocol
• Unable to speak or understand English
• Does not have a history of pancreatic cancer or is not at high risk for pancreatic cancer