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

Pancreatic Cancer Clinical Trial

— EVIS  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695966
• Other study ID #: EVIS
• Status: Completed
• Start date: May 2015
• Est. completion date: July 2018

Study information

• Verified date: July 2019
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Whipples Surgery
Whipples Surgery

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	England

Sponsors (3)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	Cancer Research UK Cambridge Institute, University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer cell distribution	Tumour tissue analysis	12 months
Primary	T lymphocyte changes	DNA, RNA and protein tumour tissue analysis	12 months
Secondary	T lymphocyte localisation	Tumour tissue analysis using study drug and other agents	12 months