EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

Chinese University of Hong Kong60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Circulating Tumor Cell

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion criteria: 1. Age \>= 18 years old 2. Newly diagnosed stage II-IV distal gastric cancer, pancreatic cancer or colorectal cancer 3. Undergoing treatment with either: 1. Surgery 2. Neoadjuvant chemotherapy 3. Neoadjuvant chemoirradiation 4. Palliative chemotherapy/ immunotherapy Exclusion criteria:  1. Synchronous cancer of other sites 2. Cardia, high lesser curve tumors, oesophagogastric junction tumors 3. Presence of bulky lymph nodes at lesser curve/ coeliac region precluding a clear EUS puncture site to portal vein and hepatic vein 4. Patients with coagulopathy (international normalized ratio \>1.3, partial thromboplastin time greater than twice that of control), platelet count \<50,000x103/uL 5. Patients unwilling to undergo follow-up assessments 6. Patients with liver cirrhosis, portal hypertension and/ or gastric varices 7. Patient refusal to participate \-

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Variant allelic fraction (expressed in %) of Genomic and proteomic analysis of ctDNA

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

Staging of the GI cancer

The pathological TNM staging of the resected specimen will be recorded.

Time frame: 3 months

Recurrence

any recurrence of the tumor will be recorded

Time frame: 5 years

Overall survival

overall survival will be recorded

Time frame: 5 years

Progression-free survival

progression free survival will be recorded

Time frame: 5 years

Technical success rate of EUS-PVA and HVA

The technical success rate of the EUS guided procedure will be recorded. Reasons for failure of the cases will be recorded.

Time frame: 1 day

Adverse events of EUS-PVA and HVA

the adverse events of the EUS procedure will be recorded

Time frame: 30 days

EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts