Clinical trial · Interventional
PDAC Peripheral and Portal Vein Sampling
A Research Protocol for Collection of Peripheral and Portal Vein Blood From Patients With Pancreatic Adenocarcinoma for Translational Research
- 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 research study in which bio-specimens (whole blood, plasma and serum from peripheral circulation and portal vein) will be collected from patients with pancreatic adenocarcinoma for translational research. These samples will be used for (but not limited to) identification and characterisation of blood-borne biomarkers at the genomic and protein expression level. Examples of such biomarkers are circulating tumour cells (CTCs), CTC clusters and circulating DNA (which can be tumour derived, or from unaffected/normal cells). CTC-enriched blood samples may also be used to generate CTC-derived tumour explant (CDX) models in immunocompromised mice in order to produce suitable disease models in which to test novel therapies and identify new molecular targets. In addition, permission will be sought from study participants for the research team to access clinical information from medical notes to aid in determining the clinical relevance of biomarkers identified during the course of this study. Validated biomarkers are anticipated to be used in designing future biomarker-directed clinical trials in these disease groups.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Portal vein sampling | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm
- description
- Observational study of CTC microemboli in portal vein blood samples.
- interventionNames
- Diagnostic Test: Portal vein sampling
Primary outcomes (1)
- measure
- Blood-borne biomarker analysis for PDAC
- timeFrame
- 12 months
- description
- To prospectively collect paired peripheral and portal vein serum, plasma and whole blood samples for translational research at various time points. To investigate the presence of Circulating Tumour Cells and Circulating Tumour Microemboli and their biological significance. To investigate potential prognostic and predictive blood-borne genetic, protein and/or messenger ribonucleic acid biomarkers using the collected specimens.
Secondary outcomes (2)
- measure
- Correlation of identified biomarkers with progression free and overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with clinically-suspected or cytologically/histologically-proven Pancreatic Adenocarcinoma who have been referred for EUS-FNA. Patients who are already on treatment would also be eligible. 2. Patients who are 18 years or older. 3. Patients must be able to receive and understand verbal and written information regarding the study and give written informed consent. 4. Patients must be able to comply with trial requirements. Exclusion Criteria: 1. Patients with other active malignancy would not be eligible with the exception of patients with squamous or basal cell carcinoma of the skin. An exception to this statement would be those patients with a known/suspected germ-line predisposition to suffer multiple malignancies, such as, but not limited to Hereditary Breast and Ovarian Cancer Syndrome (BRCA1/2), Lynch syndrome or multiple endocrine neoplasia (MEN) syndrome. 2. Patient with INR \>1.5 and/or platelets ≤50. 3. Patients with bleeding disorders. 4. Patients on anti-platelet or anti-coagulation treatment that cannot be temporarily discontinued around the procedure. 5. Patients who cannot give informed consent. 6. Patients with known Hepatitis C viral infection. 7. Patients with known Human Immunodeficiency Virus (HIV) infection. 8. If clinically judged by the investigator that the patient should not participate in the study.
References
Publications (0)
Data not yet available