EUS-guided PORtal Vein Sampling for Isolation, Enumeration and Profiling of Circulating Tumor Cells in Pancreatic Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Proportion of patients with successful aspiration of portal blood
研究概览
简要总结
The study aims at evaluating the feasibility and safety of EUS-guided Portal Circulation sampling for isolation, enumeration and profiling od Circulating Tumor Cells (CTC) in Pancreatic Cancer patients.
Patients undergoing Endoscopic Ultrasound (EUS) for cyto/histological characterization of the neoplasia will receive an additional Fine Needle Aspiration sampling of a branch of the Portal Circulation to obtain a blood sample which will be processed for CTC enrichment, count and characterization.
详细描述
Prognostic stratification of patients with Pancreatic Ductal Adenocarcinoma (PDAC) is still suboptimal, relying only on imaging studies and Carbohydrate Antigen 19.9 to drive important treatment decisions (e.g. surgery versus neoadjuvant chemotherapy).
Circulating Tumor Cells (CTCs) have been poorly evaluated in this neoplasia as they are rarely detected in the peripheral blood, whereas they are more abundantly detected in the portal circulation below the hepatic filter.
Most PDAC patients undergo Endoscopic Ultrasound (EUS) for cyto/histological characterization of the neoplasia. EUS-guided acquisition of portal blood for CTC evaluation has demonstrated its feasibility in preliminary studies without reducing the safety of the endoscopic procedure.
The study aims at collecting portal blood from PDAC patients under EUS-guidance to evaluate whether concentration and characterization of CTCs has a prognostic significance and can aid in decision making.
A paired peripheral blood sample will be acquired for comparison. Samples will be processed to obtain microfluidic enrichment of CTCs and stained with immunofluorescent antibodies for exclusion of hematopoietic cells and specific identification of CTCs, which will then be counted to obtain the blood concentration expressed as number of cells per 7.5 ml of blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with a pancreatic solid lesion undergoing EUS with a rapid on-site confirmation of a pancreatic ductal adenocarcinoma
- •patients primarily followed within San Raffaele Institute
排除标准
- •history of active non-pancreatic cancer
- •coagulopathy (INR > 1.5; platelets < 70.000/ul) or use of non-withdrawable anticoagulant or antiplatelet
- •known history or endosonographic signs of portal hypertension
- •extensive invasion of portal vein precluding needle maneuvers
- •pregnancy and breastfeeding
研究组 & 干预措施
PDAC Patients
Patients undergoing EUS for characterization of a PDAC lesion will receive EUS-guided portal blood sampling.
干预措施: EUS-guided Portal Vein sampling (Procedure)
结局指标
主要结局
Proportion of patients with successful aspiration of portal blood
时间窗: Day 1
The proportion of patients with successful needle access to the portal circulation with subsequent successful aspiration of portal blood
Proportion of patients with procedure-related Adverse Events
时间窗: 30 days
The proportion of patients experiencing procedure-related adverse events, such as bleeding or perihepatic collections.
次要结局
- Difference between Portal and Peripheral CTC concentration(Day 1)
- Baseline portal CTC concentration in patients with progressive versus non-progressive diseases(24 months)
- Portal CTC concentration according to clinical stage(Day 1)
研究者
Giuseppe Vanella
Principal Investigator
IRCCS San Raffaele