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2015-05
2018-07
2018-07
20
NCT02695966
Cambridge University Hospitals NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
OBSERVATIONAL
EVIS - Ex-vivo Assessment of T-lymphocyte Homing in Primary Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-02-23 | N/A | 2019-07-15 |
2016-02-25 | N/A | 2019-07-16 |
2016-03-02 | N/A | 2019-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | 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 | Measure Description | Time Frame |
|---|---|---|
| T lymphocyte localisation | Tumour tissue analysis using study drug and other agents | 12 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
