EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers

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 Overview

• Status: Recruiting
• Conditions: Gastrointestinal Cancer; Circulating Tumor Cell
• Intervention / Treatment: Diagnostic test: EUS-guided portal vein and hepatic vein aspiration

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shannon Chan, FRCSEd; Phone Number: 852-35052627; Email: shannonchan@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Shannon Chan, FRCSEd; Phone Number: 852-35052627; Email: shannonchan@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

      -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EUS-guided PVA and HVA; Patient will undergo EUS-guided PVA and HVA	Diagnostic test: EUS-guided portal vein and hepatic vein aspiration; EUS-guided portal vein and hepatic vein aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 %)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 %)	3 months
Staging of the GI cancer	The pathological TNM staging of the resected specimen will be recorded.	3 months
Recurrence	any recurrence of the tumor will be recorded	5 years
Overall survival	overall survival will be recorded	5 years
Progression-free survival	progression free survival will be recorded	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.	1 day
Adverse events of EUS-PVA and HVA	the adverse events of the EUS procedure will be recorded	30 days

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Gastrointestinal Cancer; Circulating Tumor Cell; Endoscopic ultrasound portal vein aspiration
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplastic Processes; Neoplasm Metastasis; Gastrointestinal Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: 2020.321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No