About the CTU

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Anglia Ruskin Clinical Trials Unit (ARCTU) is a research partnership between Anglia Ruskin Universities' Postgraduate Medical Institute, NHS Trusts from Cambridgeshire, Essex and Hertfordshire, and industry partners. Together, our NHS Trusts cover a local patient population of over 3 million. In addition, our two tertiary centres; The Essex Cardiothoracic Centre and St Andrews Burns Centre, takes this population to over 10 million.

Our aim is to work with our partner trusts in Cambridgeshire, Essex, and Hertfordshire to increase opportunities for patients to take part in both local investigator led and commercial trials.

For our investigator led trials we aim to support investigators through each step of the clinical trial lifecycle. We offer investigators the support to take their study from a basic idea and develop it into a well-designed study. An investigator can be anyone working in a clinical environment (e.g. doctors, nurses and allied health professionals).

We also work with SMEs (small to medium-sized enterprises) and larger commercial companies who are looking to test their products in a clinical environment. The support we offer ranges from providing advice on the regulatory environment in the UK, to helping to plan and run large scale studies.

Alongside the investigator initiated work, we also have a partnership with Quintiles, the world's largest Contract Research Organisation. This work supports the delivery of studies from the Quintiles pipeline at our local partner trusts.

Current projects

Title: Timing of HDR brachytherapy with EBRT in intermediate and high risk localised prostate cancer patients and its effects on toxicity and quality of life – a randomised controlled feasibility trial (THEPCA).

Prostate Cancer is the most common cancer in males in UK affecting around 105 cases for every 100,000 men. The role of radiotherapy in management of prostate cancer significantly changed over the last few decades with the developments in Brachytherapy, External Beam Radiotherapy (EBRT), Intensity modulated Radiotherapy (IMRT) and Image guided Radiotherapy (IGRT). A challenging factor of Radiotherapy treatment of localised prostate cancer is acute and late Genitourinary and Gastrointestinal toxicities.

Radiotherapy is needed to treat prostate cancer and combination of EBRT and High Dose Rate Brachytherapy is a well-recognised mode of treatment. However, it is not very clear from the evidence which sequence of the above treatments (i.e. Brachytherapy either before or after the EBRT) would result in the least side effects. The study is currently recruiting 50 patients to examine the timing of High dose rate Prostate Brachytherapy with EBRT and the side effects associated with the treatment.

Studies

Title: A study to determine the feasibility of undertaking a definitive randomised multi-centre, double-blind, double-dummy controlled study of a novel agent Anakinra, an IL-1 receptor antagonist vs. the current UK standard treatment, Depo-medrone for acute gout attacks in patients with moderate chronic kidney disease (ASGARD).

Gout is a common condition that affects 1.3 million people in the UK.  It causes very painful attacks of joint swelling, redness and tenderness.  It can affect joints of the foot, ankle, knee, hand and wrist.  It is very common in people with kidney disease, who tend to be older people with other medical conditions such as high blood pressure, heart disease and diabetes.  It is still unclear as to the safest and best way for treating an attack of gout in these patients.

The study aims to determine the feasibility of comparing the safest treatment currently available, steroids, with a new treatment that is being increasingly used, Anakinra, for acute gout attacks in patients with moderate chronic kidney disease.

Research papers

Title

Automated Quantification of Stroke Damage on Brain Computer Tomography Scans: e-ASPECTS

Authors

James Hampton-Till, Michael Harrison, Anna Luisa Kühn, Oliver Anderson, Devesh Sinha, Sharon Tysoe, Eric Greveson, Michalis Papadakis, Iris Q. Grunwald

Journal

European Medical Journal (EMJ) – Neurology

 

Title

Timing of High-Dose Rate Brachytherapy With External Beam Radiotherapy in intermediate and High-Risk Localized Prostate CAncer (THEPCA) Patients and its Effects on Toxicity and Quality of Life: Protocol of a Randomized Feasibility Trial

Authors

Sreekanth Palvai, Michael Harrison, Sharon Shibu Thomas, Karen Hayden, James Green, Oliver Anderson, Lavinia Romero, Richard Lodge, Patricia Burns, Imtiaz Ahmed

Journal

JMIR Research Protocols

Link

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4430680/

 

Key members of Staff

Michael Harrison, CTU Director

Karen Hayden, Trials Data Manager

Trisha Parker, Clinical Trials Coordinator

Michael Parker, Trials Statistician

Laura Giles, Clinical Trials Unit Administrator

 

Contact Details:

For trials related enquiries please contact Trisha Parker (Clinical Trials Coordinator)

Anglia Ruskin University

Post Graduate Medical Institute Clinical Trials Unit

Bishops Hall Lane

Chelmsford, CM1 1SQ

Trisha.parker@anglia.ac.uk

0845 196 4938

Fax: 01245 68 4437

For all other enquiries please E-mail: arctu@anglia.ac.uk