A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Last updated: May 14, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Cancer

Pancreatitis

Gastrointestinal Diseases And Disorders

Treatment

Blood Draw

Tumor Tissue Collection

Cyst Fluid

Clinical Study ID

NCT03334708
17-527
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

Cohort 1: Advanced Pancreatic Cancer Cohort Inclusion Criteria

  • Radiological, histological or cytological confirmed diagnosis of locally advanced ormetastatic 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 (previousbiopsies or surgical material).

Cohort 2: Operable Pancreatic Cancer Cohort Inclusion Criteria

  • Radiological, histological or cytological confirmed diagnosis of pancreaticadenocarcinoma 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 (previousbiopsies or surgical material).

Cohort 3: Acute Benign Pancreatic Pathology Control Inclusion Criteria

  • Confirmed diagnosis of acute pancreatitis or other acute pancreatic pathology by theenrolling 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 pancreaticpathology 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

Exclusion Criteria:

Cohort 1: Advanced Pancreatic Cancer Cohort Exclusion Criteria

  • Prior chemotherapy or radiation therapy for pancreatic cancer within the last 3months in the localized setting

  • Active second malignancy, unless low grade malignancy

  • Any medical or psychiatric condition that may interfere with ability to comply withprotocol 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 withprotocol 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 concerningfor genetic predisposition to cancer

  • Any medical or psychiatric condition that may interfere with ability to comply withprotocol 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 concerningfor genetic predisposition to cancer

  • Any medical or psychiatric condition that may interfere with ability to comply withprotocol 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 concerningfor genetic predisposition to cancer

  • Any medical or psychiatric condition that may interfere with ability to comply withprotocol 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 concerningfor genetic predisposition to cancer

  • Any medical or psychiatric condition that may interfere with ability to comply withprotocol 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 concerningfor genetic predisposition to cancer

  • Any medical or psychiatric condition that may interfere with ability to comply withprotocol procedures

Study Design

Total Participants: 700
Treatment Group(s): 3
Primary Treatment: Blood Draw
Phase:
Study Start date:
October 30, 2017
Estimated Completion Date:
October 30, 2025

Connect with a study center

  • Sha'are Zedek Medical Center

    Jerusalem, 91031
    Israel

    Site Not Available

  • Weizmann Institute of Science

    Reẖovot,
    Israel

    Site Not Available

  • Sheba Medical Center

    Tel Hashomer,
    Israel

    Active - Recruiting

  • Memoral Sloan Kettering Monmouth (All protocol activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (All protocol activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (All protocol activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Cold Springs Harbor Laboratory (Specimen Analysis)

    Cold Spring Harbor, New York 11724
    United States

    Site Not Available

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

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memoral Sloan Kettering Westchester (All protocol activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (All protocol activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memoral Sloan Kettering Basking Ridge (All protocol activitie)

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan - Kettering Cancer Center

    New York, New York 10021
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Basking Ridge (All protocol activities)

    New York, New York 10065
    United States

    Active - Recruiting

  • New York University

    New York, New York 10010
    United States

    Site Not Available

  • Weill Cornell Medical Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Nassau (All protocol activities)

    Rockville Centre, New York 11553
    United States

    Active - Recruiting

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