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
Overview
- Phase
- Not Applicable
- Intervention
- ctDNA Blood Collection
- Conditions
- Hepatobiliary Cancer
- Sponsor
- University of California, Irvine
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief 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).
Investigators
Nadine Abi-Jaoudeh
Professor of Radiological Sciences
University of California, Irvine
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
Arms & Interventions
ctDNA collection from draining and peripheral veins
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.
Intervention: ctDNA Blood Collection
Outcomes
Primary Outcomes
Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency
Time Frame: Up to 1 year
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 ctDNA compared to number of alterations derived next generation sequencing (NGS)(Up to 1 year)
- Number of unique alterations found in hepatic or portal vein plasma compared to number of alterations found in peripheral vein plasma(Up to 1 year)