Status:
COMPLETED
PDAC Peripheral and Portal Vein Sampling
Lead Sponsor:
The Christie NHS Foundation Trust
Collaborating Sponsors:
Manchester University NHS Foundation Trust
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18-80 years
Phase:
NA
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 translati...
Detailed Description
Pancreatic Ductal Adenocarcinoma (PDAC) presents an urgent medical need. Approximately 9000 new cases of pancreatic cancer are diagnosed every year in the United Kingdom (UK) and worldwide it is proje...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04289961
Start Date
June 12 2019
End Date
April 6 2023
Last Update
August 30 2023
Active Locations (2)
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1
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
2
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX