Clinical trial · Interventional
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
NCT05497531CI-TRIAL-00124665recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampullary Cancer | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatobiliary Cancer | Malignant Hepatobiliary Neoplasm | ALIAS | 0.90 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA Blood Collection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ctDNA collection from draining and peripheral veins
- description
- Patient 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.
- interventionNames
- Diagnostic Test: ctDNA Blood Collection
Primary outcomes (1)
- measure
- Comparison of the amount of ctDNA in draining vein plasma sample to peripheral vein sample through ratio of mean allele frequency
- timeFrame
- Up to 1 year
- description
- Ratio of mean allele frequency (MAF)% of hepatic or portal draining vein, and MAF% of peripheral blood will be utilized to compare the samples
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.