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Recruiting
NCT03334708
A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
Conditions: Pancreatic Cancer, Pancreatic Diseases, Pancreatitis, Pancreatic Cyst
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 120
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering Monmouth (All protocol activities) Middletown New Jersey
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 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
Source: ClinicalTrials.gov (NCT03334708). StuddyBuddy aggregates publicly available trial information.