a study of blood based biomarkers for pancreas adenocarcinoma

Conditions: Pancreatic Cancer; Pancreatic Diseases; Pancreatitis; Pancreatic Cyst

Summary: 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.


Eligibility criteria:
inclusion criteria: cohort 1: advanced pancreatic cancer cohort inclusion criteria * radiological, histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution * patient planning to receive systemic treatment * hemoglobin \> 8 * ecog performance status 0-2 * a minimum age of 18 years old * willing to undergo a tumor biopsy * willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). cohort 2: operable pancreatic cancer cohort inclusion criteria * radiological, 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 undergo a tumor biopsy * willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material). 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 chemotherapy or radiation therapy for pancreatic cancer within the last 3 months in the localized setting * active second malignancy, unless low grade malignancy * any medical or psychiatric condition that may interfere with ability to comply with protocol procedures cohort 2: operable pancreatic cancer cohort exclusion criteria * neoadjuvant chemotherapy or radiation therapy is planned * active second malignancy, unless low grade malignancy * any medical or psychiatric condition that may interfere with ability to comply with protocol procedures 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

Keywords: 17-257