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A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
NCT03334708 · Memorial Sloan Kettering Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma
About this study
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 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
Enrollment target: 700 participants
Age groups: adult, older_adult
Timeline
Starts: 2017-10-30
Estimated completion: 2026-10-30
Last updated: 2025-12-02
Interventions
Diagnostic Test: Blood DrawDiagnostic Test: Tumor Tissue CollectionDiagnostic Test: Cyst Fluid
Primary outcomes
- • Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer (4 years)
Sponsor
Memorial Sloan Kettering Cancer Center · other
With: Sheba Medical Center, Weill Medical College of Cornell University, Weizmann Institute of Science
Contacts & investigators
ContactKenneth Yu, MD · contact · yuk1@mskcc.org · 646-888-4188
ContactDavid Kelson, MD · contact · 646-888-4179
All locations (13)
Memorial Sloan Kettering Monmouth (All protocol activities)Recruiting
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All protocol activities)Recruiting
Montvale, New Jersey, United States
Cold Springs Harbor Laboratory (Specimen Analysis)Not Yet Recruiting
Cold Spring Harbor, New York, United States
Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)Recruiting
Commack, New York, United States
Memorial Sloan Kettering Westchester (All protocol activities)Recruiting
Harrison, New York, United States
New York UniversityActive Not Recruiting
New York, New York, United States
Memorial Sloan - Kettering Cancer CenterRecruiting
New York, New York, United States
Memorial Sloan Kettering Basking Ridge (All protocol activities)Recruiting
New York, New York, United States
Weill Cornell Medical CenterNot Yet Recruiting
New York, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)Recruiting
Rockville Centre, New York, United States
Sha'are Zedek Medical CenterNot Yet Recruiting
Jerusalem, Israel
Weizmann Institute of ScienceNot Yet Recruiting
Rehovot, Israel
Sheba Medical CenterRecruiting
Tel Litwinsky, Israel