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

Primary Purpose

Hepatobiliary Cancer, Pancreatic Cancer, Hepatocellular Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ctDNA Blood Collection
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatobiliary Cancer focused on measuring ctDNA, Circulating Tumor DNA, Pancreatic Cancer, Hepatobiliary Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chao Family Comprehensive Cancer Center, University of California, IrvineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ctDNA collection from draining and peripheral veins

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)

Full Information

First Posted
August 9, 2022
Last Updated
May 2, 2023
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT05497531
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatobiliary Cancer, Pancreatic Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma, Ampullary Cancer, Pancreatic Carcinoma
Keywords
ctDNA, Circulating Tumor DNA, Pancreatic Cancer, Hepatobiliary Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ctDNA collection from draining and peripheral veins
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
ctDNA Blood Collection
Intervention Description
Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy
Primary Outcome Measure Information:
Title
Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency
Description
Ratio of mean allele frequency (MAF)% of hepatic or portal draining vein, and MAF% of peripheral blood will be utilized to compare the samples
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Number of unique alterations found in hepatic or portal vein plasma compared to number of alterations found in peripheral vein plasma
Description
ctDNA results will be compared with percutaneous biopsy (standard of care)
Time Frame
Up to 1 year
Title
Number of unique alterations found in ctDNA compared to number of alterations derived next generation sequencing (NGS)
Description
ctDNA results will be compared with percutaneous biopsy (standard of care)
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Family Comprehensive Cancer Center University of California, Irvine
Phone
1-877-827-7883
Email
ucstudy@uci.edu
First Name & Middle Initial & Last Name or Official Title & Degree
University of California Irvine Medical
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Abi-Jaoudeh, MD
Organizational Affiliation
Chao Family Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center, University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadine Abi-Jaoudeh, MD
Phone
877-827-8839
Email
ucstudy@uci.edu

12. IPD Sharing Statement

Learn more about this trial

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

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