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NCT03334708RecruitingAccepts Healthy Volunteers

A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Memorial Sloan Kettering Cancer Center

Start Date

10/30/2017

Completion Date

10/30/2026

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

Age Range: 18 years to No maximum

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

Interventions

DIAGNOSTIC_TEST

Blood Draw

DIAGNOSTIC_TEST

Tumor Tissue Collection

DIAGNOSTIC_TEST

Cyst Fluid

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Conditions

Pancreatic CancerPancreatic DiseasesPancreatitisPancreatic Cyst

Locations

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey 07645

United States

Cold Springs Harbor Laboratory (Specimen Analysis)

Cold Spring Harbor, New York 11724

United States

Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York 10604

United States

New York University

New York, New York 10010

United States

Memorial Sloan - Kettering Cancer Center

New York, New York 10021

United States

Memorial Sloan Kettering Basking Ridge (All protocol activities)

New York, New York 10065

United States

Weill Cornell Medical Center

New York, New York 10065

United States

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York 11553

United States

Sha'are Zedek Medical Center

Jerusalem, 91031

Israel

Weizmann Institute of Science

Rehovot,

Israel

Sheba Medical Center

Tel Litwinsky,

Israel