PDAC Peripheral and Portal Vein Sampling

NCT04289961 | Completed

• 1 other identifier: 18_DOG03-436
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

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

Pancreatic Adenocarcinoma

Keywords

Circulating Tumour Cells (CTCs); CTC clusters; EUS-FNA; Portal Vein; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Blood-borne biomarker analysis for PDAC

  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.

  12 months

Secondary Outcomes (2)

• Correlation of identified biomarkers with progression free and overall survival

  24 months

• Investigation germline genetic biomarkers

  12-24 months

Study Arms (1)

Single Arm

OTHER

Observational study of CTC microemboli in portal vein blood samples.

Diagnostic Test: Portal vein sampling

Interventions

Portal vein sampling DIAGNOSTIC_TEST

During Endoscopic UltraSound guided-Fine Needle Aspitation (EUS-FNA) a curvilinear echoendoscope is advanced to the distal stomach or duodenal bulb to provide a window of access to a branch of the PV. After verifying venous flow by Doppler signal, a 19-gauge EUS-FNA needle is advanced transhepatically into the portal vein branch. With the needle in the portal vein, the stylet is removed and negative-pressure suction is applied to aspirate blood. A transhepatic approach for portal vein branch access is an absolute requirement of this technique in order to minimize the risk of bleeding. The puncture site is monitored under EUS for complications.

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who are 18 years or older.
• Patients must be able to receive and understand verbal and written information regarding the study and give written informed consent.
• Patients must be able to comply with trial requirements.

You may not qualify if:

• 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.
• Patient with INR \>1.5 and/or platelets ≤50.
• Patients with bleeding disorders.
• Patients on anti-platelet or anti-coagulation treatment that cannot be temporarily discontinued around the procedure.
• Patients who cannot give informed consent.
• Patients with known Hepatitis C viral infection.
• Patients with known Human Immunodeficiency Virus (HIV) infection.
• If clinically judged by the investigator that the patient should not participate in the study.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (2)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Oncology

Model Details: Prospective translational research study

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: February 28, 2020
• Study Start: June 12, 2019
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)