Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 24
- 主要终点
- Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort 1: Advanced PDAC cohort
Blood and sweat samples will be drawn from patients prior to starting treatment. A research biopsy may be performed for tissue analysis (ATAC-Array) (optional). This cohort is actively accruing.
干预措施: Blood Draw (Diagnostic Test)
Cohort 2: Operable PDAC cohort
Blood samples will be drawn from patients prior to operation. Tissue from surgical sample may be analyzed (ATAC-Array) (optional). This cohort is actively accruing.
干预措施: Blood Draw (Diagnostic Test)
Cohort 3: Acute Benign Pancreatic Pathology Cohort
Blood samples will be drawn during acute episode of disease and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.
干预措施: Blood Draw (Diagnostic Test)
Cohort 4: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts
Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.
干预措施: Blood Draw (Diagnostic Test)
Cohort 7: Healthy Controls
Blood samples will be collected at study enrollment only. This cohort is closed to accrual.
干预措施: Blood Draw (Diagnostic Test)
Cohort 1: Advanced PDAC cohort
Blood and sweat samples will be drawn from patients prior to starting treatment. A research biopsy may be performed for tissue analysis (ATAC-Array) (optional). This cohort is actively accruing.
干预措施: Tumor Tissue Collection (Diagnostic Test)
Cohort 2: Operable PDAC cohort
Blood samples will be drawn from patients prior to operation. Tissue from surgical sample may be analyzed (ATAC-Array) (optional). This cohort is actively accruing.
干预措施: Tumor Tissue Collection (Diagnostic Test)
Cohort 4: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts
Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.
干预措施: Cyst Fluid (Diagnostic Test)
Cohort 5: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts
Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.
干预措施: Blood Draw (Diagnostic Test)
Cohort 5: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts
Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.
干预措施: Cyst Fluid (Diagnostic Test)
Cohort 6: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts
Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.
干预措施: Blood Draw (Diagnostic Test)
Cohort 6: Chronic Benign Pancreatic Pathology, IPMN and Pancreatic Cyst Cohorts
Blood samples will be drawn at study enrollment and every 6 to 12 months thereafter, per institutional guidelines. This cohort is closed to accrual.
干预措施: Cyst Fluid (Diagnostic Test)
结局指标
主要结局
Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer
时间窗: 4 years
次要结局
未报告次要终点