RecruitingRecruiting
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
NCT05497531 · University of California, Irvine
In plain English
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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
About this study
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).
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
Study design
Enrollment target: 15 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-09-07
Estimated completion: 2027-06
Last updated: 2026-08-31
Interventions
Diagnostic Test: ctDNA Blood Collection
Primary outcomes
- • Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency (Up to 1 year)
Sponsor
University of California, Irvine · other
Contacts & investigators
ContactChao Family Comprehensive Cancer Center University of California, Irvine · contact · ucstudy@uci.edu · 1-877-827-7883
ContactUniversity of California Irvine Medical · contact
InvestigatorNadine Abi-Jaoudeh, MD · principal_investigator, Chao Family Comprehensive Cancer Center
All locations (1)
Chao Family Comprehensive Cancer Center, University of California, IrvineRecruiting
Orange, California, United States