Pancreatic Cancer, Pancreatic Diseases, Pancreatitis, Pancreatic Cyst
Conditions
Keywords
17-257
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.
Interventions
DIAGNOSTIC_TESTBlood Draw
If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria: Patients and controls weighing 50kg or more * For draw amounts up to 50mL, there is no required hemoglobin threshold. * For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period. Patients and controls weighing \< 50kg * For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time.
DIAGNOSTIC_TESTTumor Tissue Collection
Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
DIAGNOSTIC_TESTCyst Fluid
Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
Sponsors
Sheba Medical Center
Weill Medical College of Cornell University
Weizmann Institute of Science
Memorial Sloan Kettering Cancer Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer | 4 years |
Countries
Israel, United States
Contacts
Primary ContactKenneth Yu, MD
Backup ContactDavid Kelson, MD
Outcome results
None listed