PDAC Peripheral and Portal Vein Sampling
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|ClinicalTrials.gov Identifier: NCT04289961|
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : February 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Diagnostic Test: Portal vein sampling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective translational research study|
|Masking:||None (Open Label)|
|Official Title:||A Research Protocol for Collection of Peripheral and Portal Vein Blood From Patients With Pancreatic Adenocarcinoma for Translational Research|
|Actual Study Start Date :||June 12, 2019|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Observational study of CTC microemboli in portal vein blood samples.
Diagnostic Test: Portal vein sampling
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.
- Blood-borne biomarker analysis for PDAC [ Time Frame: 12 months ]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.
- Correlation of identified biomarkers with progression free and overall survival [ Time Frame: 24 months ]To prospectively collect progression free and overall survival data so that correlation between biomarker parameters and clinical parameters can be examined.
- Investigation germline genetic biomarkers [ Time Frame: 12-24 months ]Investigation of potential predictive blood germline genetic biomarkers using the collected specimens.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289961
|Contact: Konstantinos Georgiadis, MBBS firstname.lastname@example.org|
|Contact: Kate Vaughan, PhD||07774 335 395||Kate.Vaughan@manchester.ac.uk|
|Manchester University NHS Foundation Trust||Recruiting|
|Manchester, United Kingdom, M13 9WL|
|Contact: Alice Panes 01617011262 Alice.Panes@mft.nhs.uk|
|The Christie NHS Foundation Trust||Recruiting|
|Manchester, United Kingdom, M20 4BX|
|Contact: Kate Vaughan, PhD 07774 335 395 email@example.com|