Clinical trial NCT05497531: Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatobiliary Cancer
Pancreatic Cancer
Hepatocellular Carcinoma
Cholangiocarcinoma
Ampullary Cancer
Pancreatic Carcinoma
Keywords: ctDNA
Circulating Tumor DNA
Pancreatic Cancer
Hepatobiliary Cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of unique alterations found in hepatic or portal vein plasma compared to number of alterations found in peripheral vein plasma
timeFrame: Up to 1 year
measure: Number of unique alterations found in ctDNA compared to number of alterations derived next generation sequencing (NGS)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center, University of California, Irvine
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Nadine Abi-Jaoudeh, MD
role: PRINCIPAL_INVESTIGATOR
References: