A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Recruiting

• Conditions: Pancreatitis; Pancreatic Diseases; Pancreatic Cyst; Pancreatic Cancer

• Registration Number: NCT03334708
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-30
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-23
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer	4 years

Trial Locations

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

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