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EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

Primary Purpose

Circulating Tumor Cell, Gastrointestinal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
EUS-guided portal vein and hepatic vein aspiration
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Circulating Tumor Cell focused on measuring Circulating Tumor Cell, Gastrointestinal Cancer, Endoscopic ultrasound portal vein aspiration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

      -

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EUS-guided PVA and HVA

Arm Description

Patient will undergo EUS-guided PVA and HVA

Outcomes

Primary Outcome Measures

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 %)

Secondary Outcome Measures

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 %)
Staging of the GI cancer
The pathological TNM staging of the resected specimen will be recorded.
Recurrence
any recurrence of the tumor will be recorded
Overall survival
overall survival will be recorded
Progression-free survival
progression free survival will be recorded
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.
Adverse events of EUS-PVA and HVA
the adverse events of the EUS procedure will be recorded

Full Information

First Posted
January 5, 2021
Last Updated
March 1, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04782557
Brief Title
EUS Guided HVA and PVA for Circulating Tumor DNA in Patients
Official Title
Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circulating Tumor Cell, Gastrointestinal Cancer
Keywords
Circulating Tumor Cell, Gastrointestinal Cancer, Endoscopic ultrasound portal vein aspiration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EUS-guided PVA and HVA
Arm Type
Experimental
Arm Description
Patient will undergo EUS-guided PVA and HVA
Intervention Type
Diagnostic Test
Intervention Name(s)
EUS-guided portal vein and hepatic vein aspiration
Intervention Description
EUS-guided portal vein and hepatic vein aspiration
Primary Outcome Measure Information:
Title
Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood
Description
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 %)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Variant allelic fraction (expressed in %) of Genomic and proteomic analysis of ctDNA
Description
If ctDNA is identified, further genomic and proteomic analysis will be performed. It will be measured in terms variant allelic fraction (expressed in %)
Time Frame
3 months
Title
Staging of the GI cancer
Description
The pathological TNM staging of the resected specimen will be recorded.
Time Frame
3 months
Title
Recurrence
Description
any recurrence of the tumor will be recorded
Time Frame
5 years
Title
Overall survival
Description
overall survival will be recorded
Time Frame
5 years
Title
Progression-free survival
Description
progression free survival will be recorded
Time Frame
5 years
Title
Technical success rate of EUS-PVA and HVA
Description
The technical success rate of the EUS guided procedure will be recorded. Reasons for failure of the cases will be recorded.
Time Frame
1 day
Title
Adverse events of EUS-PVA and HVA
Description
the adverse events of the EUS procedure will be recorded
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Chan, FRCSEd
Phone
852-35052627
Email
shannonchan@surgery.cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Chan, FRCSEd
Phone
852-35052627
Email
shannonchan@surgery.cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

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EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

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