A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
Recruiting · NCT03334708 · Observational (researchers observe without assigning treatment) · Lead sponsor: Memorial Sloan Kettering Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Blood DrawCyst FluidTumor Tissue Collection
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 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 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
Where it is running
13 locations listed across 2 US states.
- 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
- Sha'are Zedek Medical Center - Jerusalem, Israel
- Sheba Medical Center - Qiryat Krinitzi, Israel
- Weizmann Institute of Science - Rehovot, Israel