Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
Part of paid clinical trials in Orange, California.
- Sponsor
- University of California, Irvine
- Study ID
- NCT05497531
- Status
- Recruiting
Conditions
- Ampullary Cancer
- Cholangiocarcinoma
- Hepatobiliary Cancer
- Hepatocellular Carcinoma
- Pancreatic Cancer
- Pancreatic Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ctDNA Blood Collection — DIAGNOSTIC_TESTBlood collection to be obtained from peripheral vein and cancer draining vein during biopsy
Study Details
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.
Key Dates
- Start date
- Sep 7, 2022
- Status verified
- Feb 2026
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: ctDNA collection from draining and peripheral veinsPatient with suspected primary hepatobiliary or pancreatic cancer undergoing a diagnostic work-up with a percutaneous or trans-jugular biopsy (standard of care) and will undergo a sampling of the cancer draining vein during their biopsy procedure with a collection of an additional 10mL of blood.
Primary Outcome Measure
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 ]
Central Contacts
- Chao Family Comprehensive Cancer Center University of California, Irvine1-877-827-7883
- University of California Irvine Medical
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center, University of California, Irvine | Orange | California | 92868 |
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