Comparing blood samples from cancer-draining veins to standard veins in patients with liver 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
NA · University of California, Irvine · NCT05497531
This study is testing if taking blood samples from veins near liver and pancreatic tumors can help find cancer DNA better than using regular veins in patients getting biopsies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine (other) |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT05497531 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates whether detecting circulating tumor DNA (ctDNA) can be improved by sampling from the cancer-draining vein instead of the standard peripheral vein in patients undergoing biopsies for hepatobiliary and pancreatic cancers. It is a prospective single-center study that aims to compare ctDNA results from both sampling methods with the standard percutaneous biopsy results. The goal is to enhance the accuracy of ctDNA detection, which could lead to better monitoring and treatment strategies for these cancers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing work-up for hepatobiliary or pancreatic carcinoma and are scheduled for a biopsy.
Not a fit: Patients with severe coagulopathy, those unable to undergo the required procedures, or those without a reachable biopsy target may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the detection of ctDNA, leading to more accurate diagnoses and treatment monitoring for patients with hepatobiliary and pancreatic cancers.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving ctDNA detection, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orange, California
- Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange, California, United States (RECRUITING)
Study contacts
- Principal investigator: Nadine Abi-Jaoudeh, MD — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 1-877-827-7883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatobiliary Cancer, Pancreatic Cancer, Hepatocellular Carcinoma, Cholangiocarcinoma, Ampullary Cancer, Pancreatic Carcinoma, ctDNA, Circulating Tumor DNA