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Barrett’s ESophagus Trial 3 (BEST3)

Full title of Study:

Barrett’s ESophagus Trial 3 (BEST3): a Trial of a new GP-based test for patients with heartburn symptoms 

Study Objectives:

Early detection of oesophageal cancer has been shown to improve patient outcomes. However, most patients with heartburn (the primary risk factor) are not investigated and most cases of oesophageal cancer present at an advanced stage.

The BEST3 Trial will assess whether the newly-developed CytospongeTM –TFF3 (Trefoil Factor 3) test for patients with reflux symptoms will be effective in increasing the detection of Barrett’s oesophagus in primary care and to evaluate its cost effectiveness. It will give us further information on the diagnostic accuracy of the CytospongeTM  -TFF3 test and will also evaluate the patient acceptability of this new diagnostic test. It is hoped that this research will establish whether the CytospongeTM -TFF3 test offers earlier detection and an alternative approach to invasive endoscopy. This will build on the previous multi-site BEST1 and BEST2 trials, providing the last step before this test could be adopted into mainstream practice in the UK. The trial will take 3 years to complete.

Study Design: The CytospongeTM TFF3 test will be trialled in GP practices using a
cutting-edge cluster randomisation approach.

 

Chief
Investigator 
Prof. Rebecca C Fitzgerald, MRC Cancer Unit at the University of Cambridge, Hutchison/MRC Research Centre, Honorary Consultant Gastroenterologist at Cambridge University Hospitals NHS Foundation Trust, Cambridge
Clinical Trial Design and Statistics         

Prof Peter Sasieni, Wolfson Institute of Prevention and Barts Clinical Trials Unit, Queen Mary, University of London

Primary Care

Prof Greg Rubin, School of Medicine, Pharmacy and Health, Durham University.

Dr Fiona Walter, Department of Public Health and Primary Care, University of Cambridge

Health Economics Prof Stephen Morris, Department of Applied Health Research, University College London

 

Trials Management: Barts Clinical Trials Unit, Centre for Cancer Prevention at Queen Mary, University of London

Number of Participants: Up to 150 GP surgeries will be randomised to either treat patients with reflux symptoms in the usual way or to invite patients to receive the CytospongeTM-TFF3 test. 9000 patients will be recruited to the trial, of which half will be invited to receive the CytospongeTM procedure.

Endpoints: Numberof Barrett’s oesophagus diagnoses in each arm, acceptability of the CytospongeTM-TFF3 test and the cost effectiveness of the test.

 

Main inclusion criteria:

-      Male and female

-      Aged 50 and above

-      Records of at least six months of prescription for acid-suppressant medication in the last year

Status of Study: In set-up. Recruitment for BEST3 is set to commence in early 2017. We are seeking GP surgeries to help with patient recruitment and to host this trial.

This is a high profile study and the research team recently received a Gastroenterology Team Award from the BMJ for their work on the CytospongeTM (Cytosponge – find cancer early).

 

Funding: CRUK