EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04782557
• Other study ID #: 2020.321
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2021
• Source: Chinese University of Hong Kong
• Contact: Shannon Chan, FRCSEd
• Phone: 852-35052627
• Email: shannonchan[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Circulating Tumor Cell
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Neoplastic Cells, Circulating

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Staging of the GI cancer	The pathological TNM staging of the resected specimen will be recorded.	3 months
Secondary	Recurrence	any recurrence of the tumor will be recorded	5 years
Secondary	Overall survival	overall survival will be recorded	5 years
Secondary	Progression-free survival	progression free survival will be recorded	5 years
Secondary	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
Secondary	Adverse events of EUS-PVA and HVA	the adverse events of the EUS procedure will be recorded	30 days