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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Hepatobiliary Cancer, Pancreatic Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma, Ampullary Cancer, Pancreatic Carcinoma

Intervention / Treatment
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* Diagnostic Test: ctDNA Blood Collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ctDNA collection from draining and peripheral veins<br>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. | Diagnostic Test: ctDNA Blood Collection<br>* Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Up to 1 year | 
| 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) | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ctDNA, Circulating Tumor DNA, Pancreatic Cancer, Hepatobiliary Cancer