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Completed

NCT Number: NCT02695966

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whipples Surgery

Procedure

Whipples Surgery

Primary outcomes

  1. Cancer cell distribution

    Time frame: 12 months

    Tumour tissue analysis

  2. T lymphocyte changes

    Time frame: 12 months

    DNA, RNA and protein tumour tissue analysis

Secondary outcomes

  1. T lymphocyte localisation

    Time frame: 12 months

    Tumour tissue analysis using study drug and other agents

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Collaborators

  • Cancer Research UK Cambridge Institute
  • University of Cambridge

Registry information

Official study title

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.

Acronym: EVIS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2016
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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