A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
- Conditions
- PancreatitisPancreatic DiseasesPancreatic CystPancreatic Cancer
- Interventions
- Diagnostic Test: Blood DrawDiagnostic Test: Tumor Tissue CollectionDiagnostic Test: Cyst Fluid
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 700
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
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
- Arm && Interventions
Group Intervention Description Acute Benign Pancreatic Pathology Control Cohort Tumor Tissue Collection For patients with acute pancreatitis, blood specimens will be drawn at the time of acute pancreatitis and every 6-12 months thereafter Chronic Benign Pancreatic Path,IPMC & Pancreatic Cyst Ctrl Cyst Fluid For patients with chronic pancreatitis, IPMN, or cysts, blood specimens will be drawn every 6-12 months. Chronic Benign Pancreatic Path,IPMC & Pancreatic Cyst Ctrl Blood Draw For patients with chronic pancreatitis, IPMN, or cysts, blood specimens will be drawn every 6-12 months. Locally Advanced or Metastatic Pancreatic Cancer Cohort Blood Draw For patients with locally advanced or metastatic PDAC, blood will be collected pre-treatment initiation (baseline), after first chemotherapy cycle, every 8-12 weeks while under treatment to coincide with restaging CT scan and at time of disease progression. Locally Advanced or Metastatic Pancreatic Cancer Cohort Tumor Tissue Collection For patients with locally advanced or metastatic PDAC, blood will be collected pre-treatment initiation (baseline), after first chemotherapy cycle, every 8-12 weeks while under treatment to coincide with restaging CT scan and at time of disease progression. Acute Benign Pancreatic Pathology Control Cohort Blood Draw For patients with acute pancreatitis, blood specimens will be drawn at the time of acute pancreatitis and every 6-12 months thereafter Chronic Benign Pancreatic Path,IPMC & Pancreatic Cyst Ctrl Tumor Tissue Collection For patients with chronic pancreatitis, IPMN, or cysts, blood specimens will be drawn every 6-12 months. Healthy Control Blood Draw For normal controls, blood specimens will be drawn once at study baseline.
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Memorial Sloan Kettering Westchester (All protocol activities)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)
🇺🇸Rockville Centre, New York, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
Sha'are Zedek Medical Center
🇮🇱Jerusalem, Israel
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
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
Weizmann Institute of Science
🇮🇱Reẖovot, Israel
New York University
🇺🇸New York, New York, United States
Memorial Sloan Kettering Basking Ridge (All protocol activities)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan - Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
🇺🇸Commack, New York, United States