Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
Recruiting · NCT05497531 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Irvine
View the official record on ClinicalTrials.gov →Interventions studied
ctDNA Blood Collection
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Chao Family Comprehensive Cancer Center, University of California, Irvine - Orange, California, United States