EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

Not Applicable

Recruiting

• Conditions: Gastrointestinal Cancer; Circulating Tumor Cell
• Interventions: Diagnostic Test: EUS-guided portal vein and hepatic vein aspiration

• Registration Number: NCT04782557
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-05
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-01
• Last Update Submitted: 2021-03-01
• Study First Posted: 2021-03-04
• Last Update Posted: 2021-03-04
• Primary Completion: 2026-01-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS-guided PVA and HVA	EUS-guided portal vein and hepatic vein aspiration	Patient will undergo EUS-guided PVA and HVA

Primary Outcome Measures

Name	Time	Method
Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood	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 %)

Secondary Outcome Measures

Name	Time	Method
Recurrence	5 years	any recurrence of the tumor will be recorded
Overall survival	5 years	overall survival will be recorded
Technical success rate of EUS-PVA and HVA	1 day	The technical success rate of the EUS guided procedure will be recorded. Reasons for failure of the cases will be recorded.
Variant allelic fraction (expressed in %) of Genomic and proteomic analysis of ctDNA	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 %)
Staging of the GI cancer	3 months	The pathological TNM staging of the resected specimen will be recorded.
Progression-free survival	5 years	progression free survival will be recorded
Adverse events of EUS-PVA and HVA	30 days	the adverse events of the EUS procedure will be recorded

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong