EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Circulating Tumor Cell Gastrointestinal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EUS-guided PVA and HVA

Patient will undergo EUS-guided PVA and HVA

Group Type EXPERIMENTAL

EUS-guided portal vein and hepatic vein aspiration

Intervention Type DIAGNOSTIC_TEST

EUS-guided portal vein and hepatic vein aspiration

Interventions

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EUS-guided portal vein and hepatic vein aspiration

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

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Eligible Sex

ALL

Accepts Healthy Volunteers

No