A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
The purpose of this study is to develop a minimally invasive test to diagnose pancreatic
 cancer at early stages of disease and monitor response to treatment.
Inclusion Criteria:

 Cohort 1: Advanced Pancreatic Cancer Cohort Inclusion Criteria

 -  Histological or cytological confirmed diagnosis of locally advanced or metastatic
 pancreatic adenocarcinoma by the enrolling institution

 -  Patient planning to receive systemic treatment

 -  For stage IV patients, if adjuvant chemotherapy and/or chemoradiation therapy was
 received for AJCC Stage I-III pancreatic adenocarcinoma, patients are eligible if the
 last systemic therapy was given more than 6 months before initiation of currently
 planned systemic therapy

 -  Hemoglobin > 8

 -  ECOG performance status 0-2

 -  A minimum age of 18 years old

 -  Willing to provide permission to obtain banked tumor tissue for analysis (previous
 biopsies or surgical material). New tumor biopsies are not required for entrance into
 the protocol.

 Cohort 2: Operable Pancreatic Cancer Cohort Inclusion Criteria

 -  Histological or cytological confirmed diagnosis of pancreatic adenocarcinoma by the
 enrolling institution

 -  Patient planned to undergo upfront resection

 -  No pre-operative systemic therapy nor chemoradiation therapy planned

 -  Hemoglobin > 8

 -  ECOG performance status 0-2

 -  A minimum age of 18 years old

 -  Willing to provide permission to obtain banked tumor tissue for analysis (previous
 biopsies or surgical material). New tumor biopsies are not required for entrance into
 the protocol.

 Cohort 3: Acute Benign Pancreatic Pathology Control Inclusion Criteria

 -  Confirmed diagnosis of acute pancreatitis or other acute pancreatic pathology by the
 enrolling institution

 -  Hemoglobin > 8

 -  ECOG performance status 0-2

 -  A minimum age of 18 years old

 Cohort 4: Chronic Benign Pancreatic Pathology Control Inclusion Criteria

 -  Confirmed diagnosis of chronic pancreatitis or other non-cystic chronic pancreatic
 pathology by the enrolling institution

 -  Hemoglobin > 8

 -  ECOG performance status 0-2

 -  A minimum age of 18 years old

 Cohort 5: IPMN Control Inclusion Criteria

 -  Confirmed diagnosis of IPMN without high risk features by the enrolling institution

 -  A minimum age of 18 years old

 Cohort 6: Pancreatic Cyst Control Inclusion Criteria

 -  Confirmed diagnosis of benign pancreatic cyst by the enrolling institution

 -  A minimum age of 18 years old

 Cohort 7: Healthy Control Inclusion Criteria

 -  A minimum age of 18 years old

 Exclusion Criteria:

 Cohort 1: Advanced Pancreatic Cancer Cohort Exclusion Criteria

 -  Prior therapy for advanced/metastatic disease

 -  Prior history of another malignancy

 -  Adjuvant therapy for resected disease within the last 6 months

 -  Active second malignancy

 -  Any medical or psychiatric condition that may interfere with ability to comply with
 protocol procedures

 -  Proven to be a carrier of a cancer susceptibility gene or family history concerning
 for genetic predisposition to cancer

 Cohort 2: Operable Pancreatic Cancer Cohort Exclusion Criteria

 -  Neoadjuvant chemotherapy or radiation therapy is planned

 -  Prior history of another malignancy, except non-melanoma skin cancer

 -  Active second malignancy

 -  Any medical or psychiatric condition that may interfere with ability to comply with
 protocol procedures

 -  Proven to be a carrier of a cancer susceptibility gene or family history concerning
 for genetic predisposition to cancer

 Cohort 3: Acute Benign Pancreatic Pathology Control Exclusion Criteria

 -  Active or prior malignancy, except prior non-melanoma skin cancer

 -  Proven to be a carrier of a cancer susceptibility gene or family history concerning
 for genetic predisposition to cancer

 -  Any medical or psychiatric condition that may interfere with ability to comply with
 protocol procedures

 Cohort 4: Chronic Benign Pancreatic Pathology Control Exclusion Criteria

 -  Active or prior malignancy, except prior non-melanoma skin cancer

 -  Proven to be a carrier of a cancer susceptibility gene or family history concerning
 for genetic predisposition to cancer

 -  Any medical or psychiatric condition that may interfere with ability to comply with
 protocol procedures

 Cohort 5: IPMN Control Exclusion Criteria

 -  IPMN with high risk features or planned resection

 -  Active or prior malignancy, except prior non-melanoma skin cancer

 -  Proven to be a carrier of a cancer susceptibility gene or family history concerning
 for genetic predisposition to cancer

 -  Any medical or psychiatric condition that may interfere with ability to comply with
 protocol procedures

 Cohort 6: Pancreatic Cyst Control Exclusion Criteria

 -  Active or prior malignancy, except prior non-melanoma skin cancer

 -  Proven to be a carrier of a cancer susceptibility gene or family history concerning
 for genetic predisposition to cancer

 -  Any medical or psychiatric condition that may interfere with ability to comply with
 protocol procedures

 Cohort 7: Healthy Control Exclusion Criteria

 -  Active or prior malignancy, except prior non-melanoma skin cancer

 -  Proven to be a carrier of a cancer susceptibility gene or family history concerning
 for genetic predisposition to cancer

 -  Any medical or psychiatric condition that may interfere with ability to comply with
 protocol procedures