NCT04782557Recruiting
EUS Guided HVA and PVA for Circulating Tumor DNA in Patients
Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers
Source: ClinicalTrials.gov · Last updated 4 Mar 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 5 Jan 2021
- Start date
- 1 Jan 2021
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Childhood cancers
- NCT number
- NCT04782557
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Jan 2021 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Synchronous cancer of other sites
- Patients with liver cirrhosis, portal hypertension and/ or gastric varices
Lab values
- Patients with coagulopathy (international normalized ratio \>1.3, partial thromboplastin time greater than twice that of control), platelet count \<50,000x103/uL
Other
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- Cardia, high lesser curve tumors, oesophagogastric junction tumors
- Presence of bulky lymph nodes at lesser curve/ coeliac region precluding a clear EUS puncture site to portal vein and hepatic vein
- Patients unwilling to undergo follow-up assessments
- Patient refusal to participate
- \-
Who the study is looking for
- Age \>= 18 years old
- Newly diagnosed stage II-IV distal gastric cancer, pancreatic cancer or colorectal cancer
- Undergoing treatment with either:
- Surgery
- Neoadjuvant chemotherapy
- Neoadjuvant chemoirradiation
- Palliative chemotherapy/ immunotherapy
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.