EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Gastrointestinal Cancer; Circulating Tumor Cell

Treatments: Diagnostic Test: EUS-guided portal vein and hepatic vein aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT04782557

2020.321

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

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   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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

EUS-guided PVA and HVA

Experimental group

Description:

Patient will undergo EUS-guided PVA and HVA

Treatment:

Diagnostic Test: EUS-guided portal vein and hepatic vein aspiration