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EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

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ClinicalTrials.gov Identifier: NCT04782557
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
CHAN SHANNON MELISSA, Chinese University of Hong Kong

Study Description
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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.

Condition or disease Intervention/treatment Phase
Circulating Tumor Cell Gastrointestinal Cancer Diagnostic Test: EUS-guided portal vein and hepatic vein aspiration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : December 31, 2026
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

      -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782557


Contacts
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Contact: Shannon Chan, FRCSEd 852-35052627 shannonchan@surgery.cuhk.edu.hk

Locations
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Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Shannon Chan, FRCSEd    852-35052627    shannonchan@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
More Information
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Responsible Party: CHAN SHANNON MELISSA, Assistant professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04782557    
Other Study ID Numbers: 2020.321
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHAN SHANNON MELISSA, Chinese University of Hong Kong:
Circulating Tumor Cell
Gastrointestinal Cancer
Endoscopic ultrasound portal vein aspiration
Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Gastrointestinal Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
 Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases