About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
ctDNA Blood Collection
Diagnostic testBlood collection to be obtained from peripheral vein and cancer draining vein during biopsy
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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)
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)
Sponsors and contacts
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