Project Survival-Prospective Biomarker Discovery

The Primary Objective of this study is to identify and validate biomarkers that can be used
for early detection and selection of personalized treatment of pancreatic diseases, including
adenocarcinoma and pancreatitis. A maximum of 600 subjects will be enrolled in this study,
including healthy volunteers, subjects with acute and chronic pancreatitis, family members at
risk for pancreatic cancer (as defined below), and subjects with all stages of pancreatic
adenocarcinoma who will contribute samples annotated with longitudinal clinical data.
Biomarkers will be investigated for potential as Theranostic, Prognostic, Diagnostic and
Therapeutic indicators among subjects with pancreatitis and pancreatic cancer.

Examples of eligible participants include:

- Healthy volunteers without any known pancreatic disease (50 subjects)

- Healthy volunteers with no known benign or malignant pancreatic disease, AND with one
first-degree relative with pancreatic cancer, OR two second-degree relatives with
pancreatic cancer. These subjects also include those who have undergone surgery for
suspected pancreatic cancer, and who are found to have a non-pancreatic cancer pathology
upon final local site or central pathology review. (100 subjects).

- Subjects diagnosed acute or chronic pancreatitis (50 subjects).

- Subjects diagnosed with early stage pancreatic cancer who undergo surgery as standard of
care therapy with or without preoperative (neoadjuvant) chemotherapy and/or radiation
therapy; subjects diagnosed with borderline pancreatic cancer, or subjects diagnosed
with locally advanced pancreatic cancer (200 subjects). Enrollment of treatment naïve
subjects with early stage pancreatic cancer is preferred.

- Subjects diagnosed with metastatic pancreatic cancer and treated with any standard of
care therapies, such as gemcitabine/Abraxane or FOLFIRINOX as front-line treatment with
or without associated radiation treatment (200 subjects). Enrollment of treatment naïve
subjects with metastatic pancreatic cancer is preferred.

Consented and enrolled subjects will be asked to participate in this study in the following
ways:

- Subjects will be asked to contribute blood (serum, buffy coat, and plasma), urine, and
saliva after enrollment, and at clinically-significant timepoints throughout their
treatment as indicated by their disease state.

- Subjects undergoing surgery for pancreatic disease will also be asked to donate diseased
and adjacent non-diseased pancreatic tissue, defined as "excess" tissue from diagnostic
or therapeutic biopsy or surgical procedures that is no longer required for standard of
care purposes.

- Examples of "excess" tissue after a standard of care surgical procedures include any/all
biopsies or resections performed and may include non-diseased pancreatic tissue and
pancreatic tumor tissue.

- These collection procedures will not alter or prolong the conduct of standard of care
surgical procedures.

Subsequent liquid non-tissue samples will be collected from all subjects at the following
clinically-relevant time points related to standard of care treatment for pancreatic disease:

- Before, at the time of, and/or after surgery to remove a pancreatic tumor or
inflammatory mass;

- before and after chemotherapy and/or radiation for cancer;

- upon local, regional, or distant progression of cancer;

- resolution of the disease process.

Blood (serum, plasma, and buffy coat), urine and saliva will not be collected more than six
(6) times in a 12 month period per subject.

Samples will be collected until the subject withdraws or the study has completed enrollment.

Inclusion Criteria:

1. Subject is over 18 years of age and has been evaluated at a participating Pancreatic
Cancer Research Team (PCRT) study site, AND

2. Subject has been recently diagnosed with pancreatic cancer (any stage) OR

3. Subject has been recently (within 12 months) diagnosed with acute or chronic
pancreatitis OR

4. A healthy individual, with no known pancreatic disease (cancerous or otherwise), AND
with one first-degree relative with pancreatic cancer, OR two second-degree relatives
with pancreatic cancer OR one who has undergone surgery for suspected pancreatic
cancer, and who is found to have a non-pancreatic cancer pathology upon final local
site or central pathology review, OR

5. A healthy individual with no known benign or malignant pancreatic disease, and no
family history of pancreatic cancer.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria
apply:

- Subject is < 18 years old.

- Subject has been diagnosed with a primary cancer other than pancreas in the past 5
years, and is currently receiving treatment for this cancer.

- Subject is a pregnant or lactating female;

- Subject is not willing or is unable to give informed consent to this study.