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

a study on Hepatobiliary Cancer Pancreatic Cancer Hepatocellular Cancer Liver Cancer Cholangiocarcinoma Ampullary Cancer Circulating Tumor DNA Carcinoma Pancreatic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
completion around
Principal Investigator
by Nadine Abi-Jaoudeh

Description

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.

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

Details

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).

Keywords

Hepatobiliary Cancer, Pancreatic Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma, Ampullary Cancer, Pancreatic Carcinoma, ctDNA, Circulating Tumor DNA, Carcinoma, Pancreatic Neoplasms, ctDNA Blood Collection, ctDNA collection from draining and peripheral veins

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • Chao Family Comprehensive Cancer Center, University of California, Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Nadine Abi-Jaoudeh
    Clinical Professor, Radiological Sciences, School of Medicine. Authored (or co-authored) 70 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT05497531
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated
Contact us about this trial