Recruiting

ctDNA IDV vs. SPV

Sponsor:

UCLA

Code:

NCT05497531

Conditions

Hepatobiliary Cancer

Pancreatic Cancer

Hepatocellular Carcinoma

Cholangiocarcinoma

Ampullary Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ctDNA Blood Collection

Study Details

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.

Conditions

Hepatobiliary Cancer

Pancreatic Cancer

Hepatocellular Carcinoma

Cholangiocarcinoma

Ampullary Cancer

Study ID

NCT05497531

Start date

Sep 7, 2022

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

ctDNA Blood Collection

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

Primary outcome measure

  • Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-7883ucstudy@uci.edu

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Nadine Abi-Jaoudeh, MD

877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Aug 31, 2026

Last verified

Feb, 2026

Keywords

  • ctDNA
  • Circulating Tumor DNA
  • Pancreatic Cancer
  • Hepatobiliary Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-08-31.