EVIS - Ex-vivo Assessment of T-lymphocyte Homing in Primary Pancreatic Cancer

Study Overview
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Brief Summary
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This is a single-centre, prospective, non-randomised research study. The research team will investigate the feasibility of assessing primary human pancreatic tissue for changes to T lymphocyte function and localisation in the presence and absence of AMD3100.

Detailed Description
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Pancreatic cancer is the fourth leading cause of cancer-related deaths in Western countries. It is a lethal disease that typically presents late, metastasises early and is resistant to conventional treatments such as radiation and chemotherapy. In 2012 there were 8700 deaths in the UK from pancreatic cancer, making it the fifth most common cause of cancer-related death. Current therapeutic strategies are aimed at extending survival as well as improving symptoms and quality of life, but although conventional chemotherapeutic agents have achieved modest clinical benefit, the need for novel therapies is great. This study proposes to extend our pre-clinical studies to develop an ex-vivo assay for the assessment of AMD3100 effectiveness in human samples. The research team will investigate the feasibility of assessing primary human pancreatic tissue for changes to T lymphocyte function and localisation in the presence and absence of AMD3100 through obtaining a blood sample and fresh pancreatic tissue intra-operatively from pancreatic tumours located in the head of the pancreas.

Official Title
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A Feasibility Study Assessing the Ability of an Ex-vivo Assay to Measure AMD3100's Ability to Overcome Tumour Immune-privilege and Bring T-lymphocytes Into Contact With Neoplastic Targets.

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: Whipples Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary pancreatic adenocarcinoma who are undergoing pancreaticoduodenectomy (Whipple's) resection. Patients who are over 18 years of age at the time of signing the informed consent form and who are physically and mentally capable of consenting. Willing and able to comply with study procedures. Exclusion Criteria: • Any condition or abnormalities that in the judgment of the investigator/surgeon/ histopathologist would place the patient at undue risk.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Whipples Surgery|Whipples Surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer cell distribution | Tumour tissue analysis | 12 months | 
| T lymphocyte changes | DNA, RNA and protein tumour tissue analysis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T lymphocyte localisation | Tumour tissue analysis using study drug and other agents | 12 months |