Clinical trial NCT04782557: 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
Overall status: RECRUITING
Phase: NA
Conditions: Circulating Tumor Cell
Gastrointestinal Cancer
Keywords: Circulating Tumor Cell
Gastrointestinal Cancer
Endoscopic ultrasound portal vein aspiration
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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:

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   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

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Primary outcomes:
measure: Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood
timeFrame: 3 months
Secondary outcomes:
measure: Variant allelic fraction (expressed in %) of Genomic and proteomic analysis of ctDNA
timeFrame: 3 months
measure: Staging of the GI cancer
timeFrame: 3 months
measure: Recurrence
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
measure: Technical success rate of EUS-PVA and HVA
timeFrame: 1 day
measure: Adverse events of EUS-PVA and HVA
timeFrame: 30 days
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: