NCT04782557 EUS Guided HVA and PVA for Circulating Tumor DNA in Patients
| NCT ID | NCT04782557 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Circulating Tumor Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: <!-- --> 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 \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04782557 clinical trial?
This trial is open to participants of all sexes, studying Circulating Tumor Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04782557 currently recruiting?
Yes, NCT04782557 is actively recruiting participants. Contact the research team at shannonchan@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT04782557 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT04782557 clinical trial?
NCT04782557 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 60 participants.