Clinical Validation of a Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer (VERIFI)

This is the second case-control study to clinically validate the multi- analyte biomarker diagnostic model, PancreaSure. Serum samples will be collected for analysis from patients with pancreatic ductal adenocarcinoma (PDAC) Stages I and II and non-PDAC controls of similar demographics who were at increased risk of PDAC because of their familial or genetic history. Investigators and patients will not receive individual patient results, therefore patient care will not be impacted by test results. Analysis of blood samples will be conducted in Immunovia's laboratory in Durham, NC by personnel who are blinded to subject data. Biomarker results will be analyzed using a predefined (locked) algorithm with predefined (locked) cut-off resulting in a positive/negative test outcome.

Inclusion criteria

• Informed consent available
• > 45 years of age
• PDAC cases

• Treatment-naïve, pathologically confirmed PDAC Stage I or Stage II
• Sporadic or familial/genetic PDAC
• Controls

• Individuals at high risk for PDAC because of their familial and/or genetic history
• Individuals at high risk for PDAC because of pancreatic cysts between 1.0cm and 3.0cm in diameter.
• Controls will be selected to have similar demographic features (age/gender) to PDAC patients

Exclusion criteria

• Prior treatment for PDAC (i.e., prior resection, radiotherapy, or chemotherapy)
• Current immunosuppressive (e.g., systemic steroid therapy) or chemotherapy
• Major surgery or significant trauma within 12 weeks prior to blood sample collection
• Non-PDAC malignancies within 3 years prior to sample collection squamous or basal cell skin carcinoma is not an exclusion criteria)
• Control patients who currently have

• biliary obstruction secondary to gallstones
• prior diagnosis or imaging evidence of chronic pancreatitis
• cystic pancreatic lesions >3.0 cm in diameter or showing worrisome features according to Fukuoka Consensus Guidelines.