Biomarkers for the Early Detection, Surveillance, and Monitoring in Patients with Locally Advanced or Metastatic Pancreatic Cancer
This study evaluates possible biomarkers for the early detection, surveillance, and monitoring in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Studying biomarkers in the laboratory may help doctors to develop a minimally invasive test to diagnose pancreatic cancer at early stages of disease and monitor response to treatment.
Inclusion Criteria
- COHORT 1 (Advanced Pancreatic Cancer Cohort): Histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution
- COHORT 1: Patient planning to receive systemic treatment
- COHORT 1: For stage IV patients, if adjuvant chemotherapy and/or chemoradiation therapy was received for American Joint Committee on Cancer (AJCC) stage I-III pancreatic adenocarcinoma, patients are eligible if the last systemic therapy was given more than 6 months before initiation of currently planned systemic therapy
- COHORT 1: Hemoglobin > 8
- COHORT 1: Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- COHORT 1: A minimum age of 18 years old
- COHORT 1: Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material); new tumor biopsies are not required for entrance into the protocol
- COHORT 2 (Operable Pancreatic Cancer Cohort): Histological or cytological confirmed diagnosis of pancreatic adenocarcinoma by the enrolling institution
- COHORT 2: Patient planned to undergo upfront resection
- COHORT 2: No pre-operative systemic therapy nor chemoradiation therapy planned
- COHORT 2: Hemoglobin > 8
- COHORT 2: ECOG performance status 0-2
- COHORT 2: A minimum age of 18 years old
- COHORT 2: Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material); new tumor biopsies are not required for entrance into the protocol
- COHORT 3 (Acute Benign Pancreatic Pathology Control): Confirmed diagnosis of acute pancreatitis or acute pancreatic pathology by the enrolling institution
- COHORT 3: Hemoglobin > 8
- COHORT 3: ECOG performance status 0-2
- COHORT 3: A minimum age of 18 years old
- COHORT 4 (Chronic Benign Pancreatic Pathology Control): Confirmed diagnosis of chronic pancreatitis or other non-cystic chronic pancreatic pathology by the enrolling institution
- COHORT 4: Hemoglobin > 8
- COHORT 4: ECOG performance status 0-2
- COHORT 4: A minimum age of 18 years old
- COHORT 5 (Intraductal Papillary Mucinous Neoplasm [IPMN] Control): Confirmed diagnosis of IPMN without high risk features by the enrolling institution
- COHORT 5: A minimum age of 18 years old
- COHORT 6 (Pancreatic Cyst Control): Confirmed diagnosis of benign pancreatic cyst by the enrolling institution
- COHORT 6: A minimum age of 18 years old
- COHORT 7 (Healthy Control): A minimum age of 18 years old
Exclusion Criteria
- COHORT 1: Prior therapy for advanced/metastatic disease
- COHORT 1: Prior history of another malignancy, except non-melanoma skin cancer
- COHORT 1: Adjuvant therapy for resected disease within the last 6 months
- COHORT 1: Active second malignancy
- COHORT 1: Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
- COHORT 1: Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
- COHORT 2: Neoadjuvant chemotherapy or radiation therapy is planned
- COHORT 2: Prior history of another malignancy, except non-melanoma skin cancer
- COHORT 2: Active second malignancy
- COHORT 2: Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
- COHORT 2: Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
- COHORT 3: Active or prior malignancy, except prior non-melanoma skin cancer
- COHORT 3: Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
- COHORT 3: Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
- COHORT 4: Active or prior malignancy, except prior non-melanoma skin cancer
- COHORT 4: Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
- COHORT 4: Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
- COHORT 5: IPMN with high risk features or planned resection
- COHORT 5: Active or prior malignancy, except prior non-melanoma skin cancer
- COHORT 5: Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
- COHORT 5: Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
- COHORT 6: Active or prior malignancy, except prior non-melanoma skin cancer
- COHORT 6: Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
- COHORT 6: Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
- COHORT 7: Active or prior malignancy, except prior non-melanoma skin cancer
- COHORT 7: Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
- COHORT 7: Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03334708.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Middletown
Montvale
New York
Commack
New York
Uniondale
West Harrison
PRIMARY OBJECTIVE:
I. Evaluate metrics of accuracy (sensitivity and specificity for binary markers and area under the curve [AUC] for continuous markers) of various promising blood-based biomarkers in pancreatic ductal adenocarcinoma (PDAC).
SECONDARY OBJECTIVES:
I. Correlation of longitudinal blood-based biomarkers results with standard clinical and radiographic assessment of treatment response.
II. Prognostic value of promising blood-based biomarkers with progression free survival (PFS) and overall survival (OS).
III. For certain biomarkers (i.e. circulating tumor deoxyribonucleic acid [DNA]), concordance between results obtained from blood samples and results obtained from tumor tissue (i.e. specific gene mutations).
EXPLORATORY OBJECTIVE:
I. Utilize tissue specimens to discover and/or study potential blood-based biomarkers at the laboratory level.
OUTLINE:
All patients undergo collection of tissue from surgery or planned biopsies. Patients with locally advanced or metastatic PDAC also undergo collection of blood at screening, 4-6 weeks after first dose of chemotherapy, at 8-9 weeks, then every 12 weeks while under treatment. Patients with resectable pancreatic cancer undergo collection of blood prior to surgery, 4-6 weeks after resection and every 12 weeks thereafter. Patients with chronic pancreatitis, intraductal papillary mucinous neoplasms (IPMN), or cysts, undergo collection of blood every 6-12 months. Patients with acute pancreatitis undergo collection of blood at the time of acute pancreatitis and every 6-12 months thereafter. Healthy controls undergo collection of blood at baseline. Specimens are analyzed for the presence, quantity and/or characteristics of potential biomarkers.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorKenneth Ho-Ming Yu
- Primary ID17-527
- Secondary IDsNCI-2017-02257
- ClinicalTrials.gov IDNCT03334708