RecruitingNot ApplicableNCT05497531
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
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
Sponsor
University of California, Irvine
Enrollment
15 participants
Start Date
Sep 7, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria8
- 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
Interventions
DIAGNOSTIC_TESTctDNA Blood Collection
Blood collection to be obtained from peripheral vein and cancer draining vein during biopsy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05497531
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