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

July 15, 2019 updated by: CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust

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.

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.

Study Overview

Status

Completed

Conditions

Pancreatic Cancer

Intervention / Treatment

Procedure: Whipples Surgery

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

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- England
  - Cambridge, England, United Kingdom, CB2 2QQ
    - Addenbrooke's Hospital

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with primary pancreatic adenocarcinoma who are undergoing pancreaticoduodenectomy (Whipple's) resection.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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	Tumour tissue analysis	12 months
T lymphocyte changes Time Frame: 12 months	DNA, RNA and protein tumour tissue analysis	12 months

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

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

University of Cambridge

Cancer Research UK Cambridge Institute

Investigators

Study Chair: James Dr Thaventhiran, University of Cambridge

Study record dates

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 Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

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.