NCT04782557

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jan 2021Dec 2026

Study Start

First participant enrolled

January 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

5 years

First QC Date

January 5, 2021

Last Update Submit

March 1, 2021

Conditions

Circulating Tumor CellGastrointestinal Cancer

Keywords

Circulating Tumor CellGastrointestinal CancerEndoscopic ultrasound portal vein aspiration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

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

    3 months

  • Staging of the GI cancer

    3 months

  • Recurrence

    5 years

  • Overall survival

    5 years

  • Progression-free survival

    5 years

  • +2 more secondary outcomes

Study Arms (1)

EUS-guided PVA and HVA

EXPERIMENTAL

Patient will undergo EUS-guided PVA and HVA

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

Interventions

EUS-guided portal vein and hepatic vein aspirationDIAGNOSTIC_TEST

EUS-guided portal vein and hepatic vein aspiration

EUS-guided PVA and HVA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • <!-- -->
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Neoplastic Cells, CirculatingGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal Diseases

Central Study Contacts

Shannon Chan, FRCSEd

CONTACT

852-35052627shannonchan@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 5, 2021

First Posted

March 4, 2021

Study Start

January 1, 2021

Primary Completion

January 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)