NCT05497531

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Sep 2022Jun 2026

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

September 7, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

August 9, 2022

Last Update Submit

February 23, 2026

Conditions

Hepatobiliary CancerPancreatic CancerHepatocellular CarcinomaCholangiocarcinomaAmpullary CancerPancreatic Carcinoma

Keywords

ctDNACirculating Tumor DNAPancreatic CancerHepatobiliary Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 1 year

Secondary Outcomes (2)

  • Number of unique alterations found in hepatic or portal vein plasma compared to number of alterations found in peripheral vein plasma

    Up to 1 year

  • Number of unique alterations found in ctDNA compared to number of alterations derived next generation sequencing (NGS)

    Up to 1 year

Study Arms (1)

ctDNA collection from draining and peripheral veins

EXPERIMENTAL

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.

Diagnostic Test: ctDNA Blood Collection

Interventions

ctDNA Blood CollectionDIAGNOSTIC_TEST

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

ctDNA collection from draining and peripheral veins

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsCarcinoma, HepatocellularCholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver Diseases

Study Officials

  • Nadine Abi-Jaoudeh, MD

    Chao Family Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

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

University of California Irvine Medical

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiological Sciences

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

September 7, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

US(1)