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

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT02695966
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief 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.

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-02
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cancer cell distribution	12 months	Tumour tissue analysis
T lymphocyte changes	12 months	DNA, RNA and protein tumour tissue analysis

Secondary Outcome Measures

Name	Time	Method
T lymphocyte localisation	12 months	Tumour tissue analysis using study drug and other agents

Trial Locations

Locations (1)

Addenbrooke's Hospital; 🇬🇧 Cambridge, England, United Kingdom