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NCT Number: NCT04782557

EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Shannon Chan, FRCSEd

CONTACT

[email protected]

852-35052627

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years old
  • Newly diagnosed stage II-IV distal gastric cancer, pancreatic cancer or colorectal cancer
  • Undergoing treatment with either:
  • Surgery
  • Neoadjuvant chemotherapy
  • Neoadjuvant chemoirradiation
  • Palliative chemotherapy/ immunotherapy

Exclusion criteria

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  • Synchronous cancer of other sites
  • Cardia, high lesser curve tumors, oesophagogastric junction tumors
  • Presence of bulky lymph nodes at lesser curve/ coeliac region precluding a clear EUS puncture site to portal vein and hepatic vein
  • Patients with coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL
  • Patients unwilling to undergo follow-up assessments
  • Patients with liver cirrhosis, portal hypertension and/ or gastric varices
  • Patient refusal to participate

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Treatment and study plan

EUS-guided portal vein and hepatic vein aspiration

Diagnostic Test

EUS-guided portal vein and hepatic vein aspiration

Primary outcomes

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

    Time frame: 3 months

    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 %)

Secondary outcomes

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

    Time frame: 3 months

    If ctDNA is identified, further genomic and proteomic analysis will be performed. It will be measured in terms variant allelic fraction (expressed in %)

  2. Staging of the GI cancer

    Time frame: 3 months

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

  3. Recurrence

    Time frame: 5 years

    any recurrence of the tumor will be recorded

  4. Overall survival

    Time frame: 5 years

    overall survival will be recorded

  5. Progression-free survival

    Time frame: 5 years

    progression free survival will be recorded

  6. Technical success rate of EUS-PVA and HVA

    Time frame: 1 day

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

  7. Adverse events of EUS-PVA and HVA

    Time frame: 30 days

    the adverse events of the EUS procedure will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Shannon Chan, FRCSEd

CONTACT

[email protected]

852-35052627

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2021
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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