Pilot Comparing CtDNA IDV Vs. SPV Sample In Pts Undergoing Biopsies For Hepatobiliary And Pancreatic Cancers

Study Overview

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

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.

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).

Hepatobiliary Cancer
Pancreatic Cancer
Hepatocellular Carcinoma
Cholangiocarcinoma
Ampullary Cancer
Pancreatic Carcinoma

DIAGNOSTIC_TEST: ctDNA Blood Collection

1491
UCI 21-124 (OTHER Identifier) (OTHER: UCI CFCCC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-08-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-01-07
First Submitted that Met QC Criteria 2022-08-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-01-09
First Posted (ACTUAL) 2022-08-11	Results First Posted N/A	Last Verified 2025-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 c	DIAGNOSTIC_TEST: ctDNA Blood Collection Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 c

DIAGNOSTIC_TEST: ctDNA Blood Collection

Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Chao Family Comprehensive Cancer Center University of California, Irvine

Phone Number: 1-877-827-7883

Email: ucstudy@uci.edu

Study Contact Backup

Name: University of California Irvine Medical

Phone Number:

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Nadine Abi-Jaoudeh, MD, Chao Family Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record