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

NCT ID: NCT05497531

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-07
• Study Completion Date: 2025-06-30

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).

Conditions

Hepatobiliary Cancer; Pancreatic Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Ampullary Cancer; Pancreatic Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ctDNA Blood Collection

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

ctDNA Blood Collection

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Nadine Abi-Jaoudeh

Professor of Radiological Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadine Abi-Jaoudeh, MD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

Role: CONTACT

ucstudy@uci.edu

1-877-827-7883

University of California Irvine Medical

Role: CONTACT

Facility Contacts

Nadine Abi-Jaoudeh, MD

Role: primary

ucstudy@uci.edu

877-827-8839

Other Identifiers

UCI 21-124

Identifier Type: OTHER

Identifier Source: secondary_id

1491

Identifier Type: -

Identifier Source: org_study_id