Project Survival-Prospective Biomarker Discovery
Project Survival-Prospective Biomarker Discovery
This sample-collection study is open to participants in several categories: healthy
 volunteers (with or without a family history of pancreatic cancer) and individuals diagnosed
 with pancreatitis or any stage of pancreatic cancer. All participants will submit urine,
 saliva and blood samples; pancreatitis and pancreatic cancer patients will also submit tissue
 samples if biopsy/ies or surgery is part of the care being provided by their doctor. In
 partnership with Berg Health, LLC, biomarkers will be investigated for potential use in early
 detection of pancreatic cancer, to determine prognosis of patients, and to find the most
 appropriate treatments for patients.
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.