Ampullary Cancer, Cholangiocarcinoma, Hepatobiliary Cancer, Hepatocellular Carcinoma, Pancreatic Cancer, Pancreatic Carcinoma
Conditions
Keywords
ctDNA, Circulating Tumor DNA, Pancreatic Cancer, Hepatobiliary Cancer
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).
Interventions
DIAGNOSTIC_TESTctDNA Blood Collection
Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | Up to 1 year | ctDNA results will be compared with percutaneous biopsy (standard of care) |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
PRINCIPAL_INVESTIGATORNadine Abi-Jaoudeh, MD
Chao Family Comprehensive Cancer Center
Outcome results
None listed