A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Pancreatic Diseases; Pancreatic Cyst; Pancreatitis; Pancreatic Cancer

Treatments: Diagnostic Test: Tumor Tissue Collection; Diagnostic Test: Cyst Fluid; Diagnostic Test: Blood Draw

Study type: Observational

Funder types: Other

Identifiers

NCT03334708

17-527

Details and patient eligibility

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

700 participants in 4 patient groups

Locally Advanced or Metastatic Pancreatic Cancer Cohort

Description:

For patients with locally advanced or metastatic PDAC, blood will be collected pre-treatment initiation (baseline), after first chemotherapy cycle, every 8-12 weeks while under treatment to coincide with restaging CT scan and at time of disease progression.

Treatment:

Diagnostic Test: Blood Draw

Diagnostic Test: Tumor Tissue Collection

Acute Benign Pancreatic Pathology Control Cohort

Description:

For patients with acute pancreatitis, blood specimens will be drawn at the time of acute pancreatitis and every 6-12 months thereafter

Treatment:

Diagnostic Test: Blood Draw

Diagnostic Test: Tumor Tissue Collection

Chronic Benign Pancreatic Path,IPMC & Pancreatic Cyst Ctrl

Description:

For patients with chronic pancreatitis, IPMN, or cysts, blood specimens will be drawn every 6-12 months.

Treatment:

Diagnostic Test: Blood Draw

Diagnostic Test: Cyst Fluid

Diagnostic Test: Tumor Tissue Collection

Healthy Control

Description:

For normal controls, blood specimens will be drawn once at study baseline.

Treatment:

Diagnostic Test: Blood Draw