Clinical trial NCT02695966: EVIS - Ex-vivo Assessment of T-lymphocyte Homing in Primary Pancreatic Cancer
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Cancer Research UK Cambridge Institute
name: University of Cambridge
First posted: 2016-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary pancreatic adenocarcinoma who are undergoing pancreaticoduodenectomy (Whipple's) resection.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cancer cell distribution
timeFrame: 12 months
measure: T lymphocyte changes
timeFrame: 12 months
Secondary outcomes:
measure: T lymphocyte localisation
timeFrame: 12 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
Study officials:
affiliation: University of Cambridge
name: James Dr Thaventhiran
role: STUDY_CHAIR
References: