The Chinese University of Hong Kong
Hong Kong
Location status: Recruiting
NCT Number: NCT04782557
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.
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Interventional
Not applicable
Hong Kong
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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EUS-guided portal vein and hepatic vein aspiration
Time frame: 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 %)
Time frame: 3 months
If ctDNA is identified, further genomic and proteomic analysis will be performed. It will be measured in terms variant allelic fraction (expressed in %)
Time frame: 3 months
The pathological TNM staging of the resected specimen will be recorded.
Time frame: 5 years
any recurrence of the tumor will be recorded
Time frame: 5 years
overall survival will be recorded
Time frame: 5 years
progression free survival will be recorded
Time frame: 1 day
The technical success rate of the EUS guided procedure will be recorded. Reasons for failure of the cases will be recorded.
Time frame: 30 days
the adverse events of the EUS procedure will be recorded
Contact information is provided by the study sponsor or research team.
Chinese University of Hong Kong
Other
Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers
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