Circulating Tumor CellNCT04782557
EUS Guided HVA and PVA for Circulating Tumor DNA in Patients
A study testing EUS-guided portal vein and hepatic vein aspiration in people with Circulating Tumor Cell and Gastrointestinal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Circulating Tumor Cell, Gastrointestinal Cancer
- What is being tested?
- EUS-guided portal vein and hepatic vein aspiration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <!-- -->
- 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
- Patients unwilling to undergo follow-up assessments
Show all 9Show fewer
- Patients with liver cirrhosis, portal hypertension and/ or gastric varices
- Patient refusal to participate
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Shannon Chan, FRCSEd, 852-35052627, shannonchan@surgery.cuhk.edu.hk
About this study
Official title: Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers
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.
Read the 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.
- Conditions
- Circulating Tumor Cell, Gastrointestinal Cancer
- Being tested
- EUS-guided portal vein and hepatic vein aspiration
- Keywords
- Circulating Tumor Cell, Gastrointestinal Cancer, Endoscopic ultrasound portal vein aspiration
- Medical subject headings
- Neoplastic Cells, Circulating, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided portal vein and hepatic vein aspirationDiagnostic test
EUS-guided portal vein and hepatic vein aspiration
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided PVA and HVA | Experimental | Patient will undergo EUS-guided PVA and HVA Receives: Diagnostic Test: EUS-guided portal vein and hepatic vein aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %)
Measured: 3 months
Secondary outcomes (7)
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 %)
Measured: 3 months
Staging of the GI cancer
The pathological TNM staging of the resected specimen will be recorded.
Measured: 3 months
Recurrence
any recurrence of the tumor will be recorded
Measured: 5 years
Overall survival
overall survival will be recorded
Measured: 5 years
Progression-free survival
progression free survival will be recorded
Measured: 5 years
Technical success rate of EUS-PVA and HVA
The technical success rate of the EUS guided procedure will be recorded. Reasons for failure of the cases will be recorded.
Measured: 1 day
Adverse events of EUS-PVA and HVA
the adverse events of the EUS procedure will be recorded
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor CellStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN SHANNON MELISSA, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782557
- Sponsor's protocol ID
- 2020.321
- Status last verified
- Mar 2021
- First submitted
- 5 Jan 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Guided Hepatic and Portal Vein Aspiration for Circulating Tumor DNA in Patients Suffering From GI Cancers
- ClinicalTrials.gov ID
- NCT04782557
- Acronym / sponsor ID
- 2020.321
- Conditions
- Circulating Tumor Cell, Gastrointestinal Cancer
- Keywords
- Circulating Tumor Cell, Gastrointestinal Cancer, Endoscopic ultrasound portal vein aspiration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-guided PVA and HVA | Experimental | Diagnostic Test: EUS-guided portal vein and hepatic vein aspirationPatient will undergo EUS-guided PVA and HVA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age >= 18 years old
- Newly diagnosed stage II-IV distal gastric cancer, pancreatic cancer or colorectal cancer
- Undergoing treatment with either:
Key exclusion criteria (9 listed)
- <!-- -->
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided portal vein and hepatic vein aspirationEUS-guided portal vein and hepatic vein aspiration | Diagnostic test | EUS-guided PVA and HVA |
Primary outcome
Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood
Time frame: 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 %)
7 secondary outcomes
Variant allelic fraction (expressed in %) of Genomic and proteomic analysis of ctDNA
Time frame: 3 months
Staging of the GI cancer
Time frame: 3 months
Recurrence
Time frame: 5 years
Overall survival
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Technical success rate of EUS-PVA and HVA
Time frame: 1 day
Adverse events of EUS-PVA and HVA
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Circulating Tumor Cell
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Recruiting
Analysis of Circulating Tumor Markers in Blood - ALCINA 5
Cancer, Lung Cancer, Non-Small Cell
RecruitingObservational study
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
Breast Neoplasms
RecruitingPhase 1
Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
Pancreatic Ductal Adenocarcinoma (PDAC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided portal vein and hepatic vein aspiration in people with Circulating Tumor Cell and Gastrointestinal Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon Chan, FRCSEd (852-35052627, shannonchan@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.