A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Memorial Sloan Kettering Cancer Center120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Pancreatic Cancer Pancreatic Diseases Pancreatitis Pancreatic Cyst

Interventions

Blood DrawDIAGNOSTIC_TEST

If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria: Patients and controls weighing 50kg or more * For draw amounts up to 50mL, there is no required hemoglobin threshold. * For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period. Patients and controls weighing \< 50kg * For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.

Tumor Tissue CollectionDIAGNOSTIC_TEST

Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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 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