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

Sponsor

University of California, Irvine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05497531

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatobiliary Cancer Pancreatic Cancer Hepatocellular Carcinoma Cholangiocarcinoma Ampullary Cancer Pancreatic Carcinoma	Diagnostic Test: ctDNA Blood Collection	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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 collection of an additional 10mL of blood.	Diagnostic Test: ctDNA Blood Collection Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy

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 collection of an additional 10mL of blood.

Diagnostic Test: ctDNA Blood Collection

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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