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

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Aug 9, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to detect cancer-related genetic material called ctDNA (circulating tumor DNA) in patients who are undergoing biopsies for certain types of liver and pancreatic cancers. The researchers want to find out if taking samples from a vein that drains the cancer (known as the cancer draining vein) will provide better results compared to the usual method of taking samples from a peripheral vein, which is further away from the tumor.

To participate in this study, individuals need to be at least 18 years old and either have a diagnosis or are being evaluated for liver or pancreatic cancers, such as hepatocellular carcinoma or cholangiocarcinoma. They must also be scheduled for a specific type of biopsy procedure. Participants will be asked to provide written consent and can expect to undergo imaging and blood sampling during the study. It's important to note that some patients may not qualify if they have certain medical conditions that could complicate the procedure. This trial is currently recruiting participants, and anyone interested should discuss it with their doctor to see if they are eligible.

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ALL

Eligibility criteria

• 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