Circulating Tumor Cell, Gastrointestinal Cancer
Conditions
Keywords
Circulating Tumor Cell, Gastrointestinal Cancer, Endoscopic ultrasound portal vein aspiration
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.
Interventions
DIAGNOSTIC_TESTEUS-guided portal vein and hepatic vein aspiration
EUS-guided portal vein and hepatic vein aspiration
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood | 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
| Measure | Time frame | Description |
|---|---|---|
| Staging of the GI cancer | 3 months | The pathological TNM staging of the resected specimen will be recorded. |
| Recurrence | 5 years | any recurrence of the tumor will be recorded |
| Overall survival | 5 years | overall survival will be recorded |
| Variant allelic fraction (expressed in %) of Genomic and proteomic analysis of ctDNA | 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 %) |
| Technical success rate of EUS-PVA and HVA | 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 | 30 days | the adverse events of the EUS procedure will be recorded |
| Progression-free survival | 5 years | progression free survival will be recorded |
Countries
Hong Kong
Contacts
Primary ContactShannon Chan, FRCSEd
Outcome results
None listed