Gastroenterology Clinical Trials Facility

The Gastroenterology Clinical Trials' Facility is a purpose-built three bed, day case facility for conducting clinical trials in Gastroenterology. It is located within the extended Endoscopy Unit on level 2 of the John Radcliffe Hospital (commissioned Q4 2009), directly below the basic science laboratories of the Translational Gastroenterology Unit and the clinical ward on level 5.

 

Background

There is a strong tradition of experimental medicine and clinical research in Oxford Gastroenterology, since Sidney Truelove conducted the first ever clinical trial in Gastroenterology in 1955 of corticosteroids for the treatment of ulcerative colitis. Oxford is extremely well placed to conduct clinical trials at a local, national and international level, owing to well defined patient populations and internationally known Gastroenterologists specialising in inflammatory bowel disease and hepatobiliary medicine.

 

Highlights for Gastroenterology and Hepatobiliary clinical trials in Oxford

 

Income

The CTF has two sources of income from studies:

1. Commercially funded studies, through the Nufffield Department of Medicine (contact jo.hovard@ndm.ox.ac.uk, or simon.travis@ndm.ox.ac.uk)

2. UK Clinical Research Network (UKCRN) 'Portfolio' studies, through the Thames Valley local clinical Research Network (contact Morag.Burton@orh.nhs.uk, TV CLRN Industry Manager 01865 226640)

 

Current trials

If interested in any of these, contact us on 01865 221187 or endoscopy.researchsisters@orh.nhs.uk

PEACE

For patients with mild-moderate active Crohn's disease. The aim of this international study is to determine whether high dose mesalazine (6g/day) is an effective treatment alternative for active Crohn's disease. Other medical treatment (including steroids, or azathioprine) is not increased.

http://clinicaltrials.gov/ct2/show/NCT00862121

 

NEWS 80

For patients with mild-moderate active ulcerative colitis. The aim this sham-controlled, international study of leucocytapheresis is to determine whether this blood filtering device that removes activated inflammatory cells, is effective for treating active ulcerative colitis, without other medical treatment.

 

TOPPIC

For patients within 3 months of surgical resection for Crohn's disease. The aim of this national UK study is to determine whether mercaptopurine prevents recurrence of Crohn's disease after resection.

 http://www.clinicaltrials.ed.ac.uk/CurrentTrials.aspx

CONSTRUCT

For in-patients with acute severe ulcerative colitis. The aim of this national UK study is to determine whether infliximab or ciclosporin is more effective for colitis that is not responding to intravenous steroids

 

ASTIC

For patients with severe, active Crohn's disease. The aim of this international study is to determine whether autologous stem cell transplantation  is effective for severe Crohn's disease that has not responded  to conventional or biological therapy (either infliximab or adalimumab).

http://www.nottingham.ac.uk/icr/astic/

 

PYRAMID

For patients on adalimumab for Crohn's disease. The aim is to document the consequences of treatment with adalimumab over an extended (5 year) period.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2727899/

 

INTERCEPT

For patients with Primary Biliary Cirrhosis. The aim is to test a novel treatment (INT-747) with and without ursodeoxycholic acid. Study continues, but closed to new recruits.

http://clinicaltrials.gov/ct2/show/NCT00550862

 

An extended genome wide association study in coeliac disease

For any patient with coeliac disease. The aim of this study being lead by Professor David Van Heel in London, is to collect genetic material (a sample of saliva), so that DNA can be extracted and genotyped to determine susceptibility to gluten sensitivity (coeliac disease). This can be arranged by post.

 

Contact us:

Clinical trials administrator: Jo Hovard, jo.hovard@ndm.ox.ac.uk

Research Sister: Madeleine Thyssen 01865 221187, endoscopy.researchsisters@orh.nhs.uk

Lead clinician: Dr Simon Travis 01865 228753, simon.travis@ndm.ox.ac.uk