|
A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma
RECRUITINGSponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
SponsorMemorial Sloan Kettering Cancer Center
Started2017-10-30
Est. completion2026-10-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →
NCT03334708
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions5
CancerPancreatic CancerPancreatic CystPancreatic DiseasesPancreatitis
Locations10 sites
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Kenneth Yu, MD, M.Sc.646-888-4188
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645
Kenneth Yu, MD, M.Sc.646-888-4188
Cold Springs Harbor Laboratory (Specimen Analysis)
Cold Spring Harbor, New York, 11724
David Tuveson, MD, PhD516-367-5246
Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
Commack, New York, 11725
Kenneth Yu, MD, M.Sc.646-888-4188
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Kenneth Yu, MD, M.Sc.646-888-4188
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
SponsorMemorial Sloan Kettering Cancer Center
Started2017-10-30
Est. completion2026-10-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →
NCT03334708