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RECRUITINGOBSERVATIONAL

A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 - You should be able to carry out daily activities with 0 level of ability (ECOG 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 - You should be able to carry out daily activities with 0 level of ability (ECOG 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 - You should be able to carry out daily activities with 0 level of ability (ECOG 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 - You should be able to carry out daily activities with 0 level of ability (ECOG 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

Blood Draw

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.

DIAGNOSTIC_TEST

Tumor Tissue Collection

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

DIAGNOSTIC_TEST

Cyst Fluid

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

Locations (13)

Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States
Cold Springs Harbor Laboratory (Specimen Analysis)
Cold Spring Harbor, New York, United States
Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States
New York University
New York, New York, United States
Memorial Sloan - Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Basking Ridge (All protocol activities)
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States
Sha'are Zedek Medical Center
Jerusalem, Israel
Weizmann Institute of Science
Rehovot, Israel
Sheba Medical Center
Tel Litwinsky, Israel