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NCT05497531NARecruiting

Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers

University of California, Irvine

Start Date

9/7/2022

Completion Date

6/1/2026

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DIAGNOSTIC_TEST

ctDNA Blood Collection

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Conditions

Hepatobiliary CancerPancreatic CancerHepatocellular CarcinomaCholangiocarcinomaAmpullary CancerPancreatic Carcinoma

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California 92868

United States