Status:
RECRUITING
A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Sheba Medical Center
Weill Medical College of Cornell University
Conditions:
Pancreatic Cancer
Pancreatic Diseases
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT03334708
Start Date
October 30 2017
End Date
October 30 2026
Last Update
December 2 2025
Active Locations (13)
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1
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States, 07748
2
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States, 07645
3
Cold Springs Harbor Laboratory (Specimen Analysis)
Cold Spring Harbor, New York, United States, 11724
4
Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
Commack, New York, United States, 11725