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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

Tracking Information
First Submitted Date  ICMJE January 5, 2021
First Posted Date  ICMJE March 4, 2021
Last Update Posted Date March 4, 2021
Actual Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date January 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2021)		 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 %)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2021)
  • 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 %)
  • Staging of the GI cancer [ Time Frame: 3 months ]
    The pathological TNM staging of the resected specimen will be recorded.
  • Recurrence [ Time Frame: 5 years ]
    any recurrence of the tumor will be recorded
  • Overall survival [ Time Frame: 5 years ]
    overall survival will be recorded
  • Progression-free survival [ Time Frame: 5 years ]
    progression free survival will be recorded
  • 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.
  • Adverse events of EUS-PVA and HVA [ Time Frame: 30 days ]
    the adverse events of the EUS procedure will be recorded
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EUS Guided HVA and PVA for Circulating Tumor DNA in Patients
Official Title  ICMJE Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Circulating Tumor Cell
  • Gastrointestinal Cancer
Intervention  ICMJE Diagnostic Test: EUS-guided portal vein and hepatic vein aspiration
EUS-guided portal vein and hepatic vein aspiration
Study Arms  ICMJE Experimental: EUS-guided PVA and HVA
Patient will undergo EUS-guided PVA and HVA
Intervention: Diagnostic Test: EUS-guided portal vein and hepatic vein aspiration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2021)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date January 1, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

      -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shannon Chan, FRCSEd 852-35052627 shannonchan@surgery.cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04782557
Other Study ID Numbers  ICMJE 2020.321
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party CHAN SHANNON MELISSA, Chinese University of Hong Kong
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chinese University of Hong Kong
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese University of Hong Kong
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP