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A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Recruiting
18 years and older
All
Phase N/A

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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.

Eligibility

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

Study details
    Pancreatic Cancer
    Pancreatic Diseases
    Pancreatitis
    Pancreatic Cyst

NCT03334708

Memorial Sloan Kettering Cancer Center

31 July 2025

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