Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ctDNA Blood Collection.
- Who it may be relevant to
- Registry conditions: Hepatobiliary Cancer, Pancreatic Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed 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).
Interventions
- Diagnostic test ctDNA Blood Collection
Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Number of unique alterations found in hepatic or portal vein plasma compared to number of alterations found in peripheral vein plasma [Time frame: Up to 1 year]
- Number of unique alterations found in ctDNA compared to number of alterations derived next generation sequencing (NGS) [Time frame: Up to 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange
Identifiers
NCT: NCT05497531 · 1491 · UCI 21-124