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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
Sponsor:
Collaborator:
Manchester University NHS Foundation Trust
Information provided by (Responsible Party):
Juan Valle, The Christie NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Diagnostic Test: Portal vein sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective translational research study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
Single Arm
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Investigation germline genetic biomarkers [ Time Frame: 12-24 months ]
    Investigation of potential predictive blood germline genetic biomarkers using the collected specimens.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Konstantinos Georgiadis, MBBS equivalent 07462762287 konstantinos.georgiadis@manchester.ac.uk
Contact: Kate Vaughan, PhD 07774 335 395 Kate.Vaughan@manchester.ac.uk

Locations
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United Kingdom
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    kate.vaughan@manchester.ac.uk   
Sponsors and Collaborators
The Christie NHS Foundation Trust
Manchester University NHS Foundation Trust
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Responsible Party: Juan Valle, Professor of Medical Oncology, The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04289961    
Other Study ID Numbers: 18_DOG03-436
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Identifiable personal data (IPD) will be reviewed by the investigators listed on the trial delegation log at the stage of reviewing the medical records during the hepatopancreatobiliary (HPB) MultiDisciplinary Team (MDT) meeting at Manchester University Foundation Trust where the recruitment process will start. The medical notes will also be reviewed to correlate biomarker research with clinical outcomes. However, no participants' identifiable information will be shared with anyone outside the clinical or research team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan Valle, The Christie NHS Foundation Trust:
Circulating Tumour Cells (CTCs)
CTC clusters
EUS-FNA
Portal Vein
Biomarkers
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms