Health TrialsbyHealthPanel

EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

ConditionsCirculating Tumor CellGastrointestinal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChinese University of Hong Kong

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years old

Newly diagnosed stage II-IV distal gastric cancer, pancreatic cancer or colorectal cancer

Surgery

Neoadjuvant chemotherapy

Disqualifiers

Synchronous cancer of other sites

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 with coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL

Trial design

Design model

Single group

Treatments tested in this trial

  • EUS-guided portal vein and hepatic vein aspiration

    Diagnostic test

    EUS-guided portal vein and hepatic vein aspiration

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: EUS-guided PVA and HVAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood

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 %)

Time frame
3 months

Secondary outcomes

1

Variant allelic fraction (expressed in %) of Genomic and proteomic analysis of ctDNA

If ctDNA is identified, further genomic and proteomic analysis will be performed. It will be measured in terms variant allelic fraction (expressed in %)

Time frame
3 months
2

Staging of the GI cancer

The pathological TNM staging of the resected specimen will be recorded.

Time frame
3 months
3

Recurrence

any recurrence of the tumor will be recorded

Time frame
5 years
4

Overall survival

overall survival will be recorded

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
Apply now