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RecruitingInterventional

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

NCT ID: NCT05497531Sponsor: University of California, IrvineLast updated: 2026-02-24

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.

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).

Arms & interventions

  • Diagnostic TestctDNA Blood Collection

    Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy

Outcome measures

Primary

  • 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

    Time frame: Up to 1 year

Secondary

  • Number of unique alterations found in hepatic or portal vein plasma compared to number of alterations found in peripheral vein plasma

    Time frame: Up to 1 year

  • Number of unique alterations found in ctDNA compared to number of alterations derived next generation sequencing (NGS)

    Time frame: Up to 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868

Recruiting
Nadine Abi-Jaoudeh, MD · Contact
877-827-8839ucstudy@uci.edu