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

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

NCT ID: NCT05497531

Condition: Hepatobiliary Cancer
Pancreatic Cancer
Hepatocellular Carcinoma
Cholangiocarcinoma
Ampullary Cancer
Pancreatic Carcinoma

Conditions: Official terms:
Carcinoma
Pancreatic Neoplasms
Cholangiocarcinoma

Conditions: Keywords:
ctDNA
Circulating Tumor DNA
Pancreatic Cancer
Hepatobiliary Cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: ctDNA Blood Collection
Description: Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy
Arm group label: ctDNA collection from draining and peripheral veins

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).

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

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

Address:
City: Orange
Zip: 92868
Country: United States

Status: Recruiting

Contact:
Last name: Nadine Abi-Jaoudeh, MD

Phone: 877-827-8839
Email: ucstudy@uci.edu

Start date: September 7, 2022

Completion date: October 2024

Lead sponsor:
Agency: University of California, Irvine
Agency class: Other

Source: University of California, Irvine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05497531