Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood
研究概览
简要总结
The discovery of cell-free circulating tumor DNA (crDNA) in blood and the maturation of technologies for ctDNA analysis have presented an attractive opportunity for minimally invasive "liquid biopsy" genomic diagnostics. The investigators plan to perform EUS-guided portal vein and hepatic vein aspiration in GI cancers patients. The aim of the current study is thus to examine the concentration of ctDNA in portal vein (EUS-guided PVA), hepatic vein (EUS-guided HVA) and peripheral blood to understand the first pass effect of the liver with gastrointestinal (GI) cancers, and the possibility of using ctDNA as a marker for preoperative staging, restaging after neoadjuvant chemotherapy, and monitoring for recurrence.
详细描述
The discovery of cell-free circulating tumor DNA (crDNA) in blood and the maturation of technologies for ctDNA analysis have presented an attractive opportunity for minimally invasive "liquid biopsy" genomic diagnostics. The investigators plan to perform EUS-guided portal vein and hepatic vein aspiration in GI cancers patients. The aim of the current study is thus to examine the concentration of ctDNA in portal vein (EUS-guided PVA), hepatic vein (EUS-guided HVA) and peripheral blood to understand the first pass effect of the liver with gastrointestinal (GI) cancers, and the possibility of using ctDNA as a marker for preoperative staging, restaging after neoadjuvant chemotherapy, and monitoring for recurrence.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years old
- •Newly diagnosed stage II-IV distal gastric cancer, pancreatic cancer or colorectal cancer
- •Undergoing treatment with either:
- •Neoadjuvant chemotherapy
- •Neoadjuvant chemoirradiation
- •Palliative chemotherapy/ immunotherapy
排除标准
- •Synchronous cancer of other sites
- •Cardia, high lesser curve tumors, oesophagogastric junction tumors
- •Presence of bulky lymph nodes at lesser curve/ coeliac region precluding a clear EUS puncture site to portal vein and hepatic vein
- •Patients with coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL
- •Patients unwilling to undergo follow-up assessments
- •Patients with liver cirrhosis, portal hypertension and/ or gastric varices
- •Patient refusal to participate
研究组 & 干预措施
EUS-guided PVA and HVA
Patient will undergo EUS-guided PVA and HVA
干预措施: EUS-guided portal vein and hepatic vein aspiration (Diagnostic Test)
结局指标
主要结局
Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood
时间窗: 3 months
Plasma DNA will be extracted using the QIAamp Circulating Nucleic Acid Kit (Qiagen), and the concentration of the circulating tumor DNA will be reported in variant allelic fraction (expressed in %)
次要结局
- Recurrence(5 years)
- Overall survival(5 years)
- Technical success rate of EUS-PVA and HVA(1 day)
- Variant allelic fraction (expressed in %) of Genomic and proteomic analysis of ctDNA(3 months)
- Staging of the GI cancer(3 months)
- Progression-free survival(5 years)
- Adverse events of EUS-PVA and HVA(30 days)
研究者
CHAN SHANNON MELISSA
Assistant professor
Chinese University of Hong Kong