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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05497531
Other study ID # UCI 21-124 [IRB# 1491]
Secondary ID 1491
Status Recruiting
Phase N/A
First received
Last updated
Start date September 7, 2022
Est. completion date April 2024

Study information

Verified date May 2023
Source University of California, Irvine
Contact Chao Family Comprehensive Cancer Center University of California
Phone 1-877-827-7883
Email ucstudy@uci.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Diagnostic Test:
ctDNA Blood Collection
Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy

Locations

Country Name City State
United States Chao Family Comprehensive Cancer Center, University of California, Irvine Orange California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of unique alterations found in hepatic or portal vein plasma compared to number of alterations found in peripheral vein plasma ctDNA results will be compared with percutaneous biopsy (standard of care) Up to 1 year
Secondary Number of unique alterations found in ctDNA compared to number of alterations derived next generation sequencing (NGS) ctDNA results will be compared with percutaneous biopsy (standard of care) Up to 1 year
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