Hepatobiliary CancerNCT05497531
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
A study testing ctDNA Blood Collection in people with Hepatobiliary Cancer and Pancreatic Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a prospective pilot protocol investigating whether ctDNA detection be improved by sampling the cancer draining vein versus the standard practice of sampling from a peripheral vein in patients who are undergoing biopsies for hepatobiliary and pancreatic cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatobiliary Cancer, Pancreatic Cancer, Hepatocellular Carcinoma
- What is being tested?
- ctDNA Blood Collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to Jun 2027
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Have or are undergoing work-up for hepatobiliary and/or pancreatic carcinoma (such as hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, pancreatic carcinoma)
- Scheduled for an image-guided percutaneous or trans-jugular biopsy of a lesion
- Must be able to provide a written informed consent
Who cannot join
- Patients unable to hold reasonably still on a procedure table or hold their breath during imaging or needle passes
- Patients with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)
- Patients with uncorrectable coagulopathy
- Platelet count < 30,000/ul
- International Normalized (INR) > 1.5
- Patients with moderate to severe ascites who cannot undergo trans-jugular biopsy or sufficient drainage
- No clear reachable target for percutaneous or trans-jugular biopsy
- Patient who cannot have a peripheral blood draw for ctDNA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Nadine Abi-Jaoudeh, MD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: Pilot Trial Comparing Circulating Tumor DNA (ctDNA) From Immediate Draining Vein vs. Standard Peripheral Vein Sample in Patients Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
This is a prospective pilot protocol investigating whether ctDNA detection be improved by sampling the cancer draining vein versus the standard practice of sampling from a peripheral vein in patients who are undergoing biopsies for hepatobiliary and pancreatic cancers.
Read the detailed description
This is a, prospective single center pilot study to investigate whether ctDNA detection can be improved by sampling the cancer draining vein vs. a peripheral vein (current practice). As a secondary endpoint, both ctDNA results will be compared with percutaneous biopsy (standard of care).
- Conditions
- Hepatobiliary Cancer, Pancreatic Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma, Ampullary Cancer, Pancreatic Carcinoma
- Being tested
- ctDNA Blood Collection
- Keywords
- ctDNA, Circulating Tumor DNA, Pancreatic Cancer, Hepatobiliary Cancer
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA Blood CollectionDiagnostic test
Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy
| Study group | Role | What they receive |
|---|---|---|
| ctDNA collection from draining and peripheral veins | Experimental | Patient with suspected primary hepatobiliary or pancreatic cancer undergoing a diagnostic work-up with a percutaneous or trans-jugular biopsy (standard of care) and will undergo a sampling of the cancer draining vein during their biopsy procedure with a collection of an additional 10mL of blood. Receives: Diagnostic Test: ctDNA Blood Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency
Ratio of mean allele frequency (MAF)% of hepatic or portal draining vein, and MAF% of peripheral blood will be utilized to compare the samples
Measured: Up to 1 year
Secondary outcomes (2)
Number of unique alterations found in hepatic or portal vein plasma compared to number of alterations found in peripheral vein plasma
ctDNA results will be compared with percutaneous biopsy (standard of care)
Measured: Up to 1 year
Number of unique alterations found in ctDNA compared to number of alterations derived next generation sequencing (NGS)
ctDNA results will be compared with percutaneous biopsy (standard of care)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start7 Sep 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary CancerStudies of the same condition, open and under way.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Abi-Jaoudeh, University of California, Irvine
- Investigators
- Nadine Abi-Jaoudeh, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497531
- Sponsor's protocol ID
- 1491
- Other IDs
- UCI 21-124
- Status last verified
- Feb 2026
- First submitted
- 9 Aug 2022
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No