Longitudinal Pancreatic Cancer Study

The study objectives are described below:

1. Obtain serum and plasma specimens longitudinally collected from approximately 140
subjects diagnosed with pancreatic cancer and are about to or are currently undergoing
treatment and follow-up. Specimens will be used to evaluate CA 19-9 assays, currently
under development, as an aid for monitoring recurrence or progressive disease.

2. To store any remaining specimens for use in future cancer research and to evaluate as
yet undetermined biomarkers for the development of IVDs, including additional CA 19-9
assays, for monitoring the course of disease and therapy in subjects diagnosed with
pancreatic cancer.

Inclusion Criteria:

- Males and females, age≥ 18 years

- Histologic/pathologic confirmation of exocrine pancreatic cancer

- Any stage of disease: Newly diagnosed, stable, disease progression

- Any treatment time point: Treatment naïve, currently receiving or completed therapy
for pancreatic cancer including active monitoring.

- Individuals with a history of malignant disease other than pancreatic cancer that was
resected greater than 5 years ago and are currently in remission are eligible.

- Life expectancy greater than 6 months

- Able to understand and willing to provide informed consent

Exclusion Criteria:

- Males and females, age <18 years

- No histologic/pathologic confirmation of exocrine pancreatic cancer

- Life expectancy less than 6 months

- Any concurrent malignancy other than basal or squamous cell skin cancers or in-situ
cervical cancer.

- Unable to provide informed consent