- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02695966
EVIS - Ex-vivo Assessment of T-lymphocyte Homing in Primary Pancreatic Cancer (EVIS)
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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England
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Cambridge, England, United Kingdom, CB2 2QQ
- Addenbrooke's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer cell distribution
Time Frame: 12 months
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Tumour tissue analysis
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12 months
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T lymphocyte changes
Time Frame: 12 months
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DNA, RNA and protein tumour tissue analysis
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T lymphocyte localisation
Time Frame: 12 months
|
Tumour tissue analysis using study drug and other agents
|
12 months
|
Collaborators and Investigators
Investigators
- Study Chair: James Dr Thaventhiran, University of Cambridge
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EVIS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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