Impact of Echo-endoscopy Biopsy on the Circulating Tumor Cell Level in the Portal System in Pancreatic Adenocarcinoma Management Care
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Procedure impact
研究概览
简要总结
The aim of this work is to evaluate the impact of endoscopic procedures on the circulating tumoral cells level in order to evaluate the potential effects of an endoscopic procedure in the management of pancreatic tumors.
详细描述
The study will include 42 evaluable patients suspected of having pancreatic cancer and for whom an echo-endoscopic biopsy (EUS-FNA) and/or biliary drainage is planned.
In these patients, a 6 ml blood sample will be taken from the portal vein before and after the echo-endoscopic biopsy of the pancreatic mass to determine:
- the level of circulating tumor cells (CTC) per milliliter of blood,
- cytological characteristics of CTCs (isolated, clustered, giant, and clustered including other cell types).
A peripheral blood sample will also be taken to evaluate peripheral CTC levels and cytological characteristics before and after biopsy, as well as one month after biopsy.
Patients will be evaluated every 6 months as part of their follow-up to assess the progression of their pathology and morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 40-85 years old;
- •BMI< 30 kg/m2;
- •Patients suspected of having pancreatic cancer for whom an ultrasound endoscopic biopsy and/or biliary drainage is planned;
- •Affiliation to, or beneficiary of, a social security scheme.
排除标准
- •Woman who is pregnant or likely to become pregnant (without effective contraception) or breastfeeding ;
- •Person in an emergency situation, person of full age subject to a legal protection measure, or unable to express consent;
- •Biliary drainage or attempt at prior biliary drainage outside the center ;
- •Preliminary oncological treatment for pancreatic pathology covered by the study;
- •Clinical and/or image-visible (CT/MRI) carcinosis ;
- •Ascites visible on imaging (CT/MRI) ;
- •Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons;
- •Contraindications to an endoscopic procedure.
研究组 & 干预措施
Portal vein blood sample
干预措施: Blood sample in portal vein (Procedure)
结局指标
主要结局
Procedure impact
时间窗: 5 minutes after procedure
Rate of patients with a CTC increase \> 4 cells/ml in the portal system after the endoscopic procedure
次要结局
未报告次要终点