BEST4 Screening Trial
Research type
Research Study
Full title
Barrett’s oESophagus Trial 4 (BEST4): A Randomised Control Trial Comparing capsule sponge Test Screening to Usual Care
IRAS ID
332589
Contact name
Rebecca Fitzgerald
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
2 years, 10 months, 31 days
Research summary
The aim of the trial is to assess the use of the capsule sponge device as a screening tool to identify signs of the premalignant condition Barret's Oesophagus (BO), which can often be a precursor for Oesophageal Adenocarcinoma (OAC). This will be assessed in participants who are on medication (prescribed or self-medicated) for heartburn symptoms.
Using the capsule sponge device could be a simple, alternative method of screening for these conditions. The current screening method for patients who are identified as being high risk is endoscopy, which is an invasive and uncomfortable procedure, as well as being expensive for the NHS and often not easily accessible. Endoscopies can only be performed by specialist, who require rigorous training. The study will identify if the capsule sponge procedure is viable alternative to this process and whether it could improve OAC-associated late stage disease and death rates.
The other aim of the trial is to build a cohort of participants with Gastro-oesophageal reflux disease GORD, who have consented to health-related data collection and to be contacted further regarding research opportunities. This cohort has been named the 'Heartburn Health Programme' and will be used to recruit participants for the Screening Trial, based on the 'Zelen design'.
The Zelen Design randomises participants prior to consent and only the intervention arm provides informed consent. Participants will be invited to join the Heartburn Health Programme and then be randomised. Only the intervention cohort will be offered the opportunity to have a capsule sponge test and consent to the screening trial.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
24/WM/0017
Date of REC Opinion
12 Mar 2024
REC opinion
Further Information Favourable Opinion