Trial Design

The Screening Trial is a randomised controlled trial aiming to recruit 120,000 people with heartburn over a three-year period.   Men aged 55-79 and women aged 65-79 taking regular acid-suppressant medications living in select areas in England may be invited via text message to participate in BEST4.  

People will be identified by NHS England data and invited via text message to complete a survey about heartburn-related symptoms and PPI prescriptions to assess eligibility and enrol. The study will compare standard care (N=80,000) with the Capsule sponge test, with 40,000 participants attending mobile units in the community for the test. 

Referral to the NHS  

All participants with a positive TFF3 test result on the capsule sponge will be offered an endoscopy to confirm the diagnosis of Barrett’s oesophagus and inform treatment. Endoscopies will be performed at selected trusts, as near as possible to the patient’s address. Receiving Trusts are responsible for the clinical management of the participants referred. Any diagnostic work up is outside of the trial and should be conducted according to national and local guidance for urgent suspected cancer referrals (two-week wait or rapid diagnostic pathways). 

Participant Results  

Negative results – no further GP action required   

Patients will receive negative results via a text message. You will NOT receive a letter from the study team to inform you of patient involvement.   

Negative results, other relative clinical findings – GP review required   

Study team will send a letter for each patient, with report findings. Some cases may require gastroenterology advice or referral for endoscopy if clinically indicated.   

Insufficient sample – GP review potentially required   

A letter will be sent for each patient. Patients will be safety netted and if symptomatic or concerns recommended to have a clinical review.  

Positive results – no further GP action required   

Patients will be contacted by the Clinical study team to discuss their results and invited to attend an Endoscopy at the local participating Secondary Care site. The referral will be made by the Clinical study team via ERS. The GP will be notified by letter out of courtesy. No further action will be required unless patient declines endoscopy. 

After a diagnosis of Barrett’s oesophagus, it is crucial to establish an effective surveillance strategy that balances ongoing monitoring with the burden on endoscopy services. The BEST4 Surveillance Trial aims to assess the feasibility of integrating the Capsule sponge and a clinical laboratory biomarker panel into the surveillance approach for patients with non-dysplastic Barrett’s oesophagus. This combined strategy has the potential to reduce the reliance on frequent endoscopy procedures, leading to substantial cost savings for the NHS while ensuring appropriate monitoring for patients with Barrett’s oesophagus. 

Eligible people include those undergoing routine endoscopic surveillance with known Barrett’s or those diagnosed with Barrett’s as part of the BEST4 Screening Trial. We will aim to recruit a total of 2000 people over 2 years. 

Participants will receive the capsule sponge test in addition to their standard of care endoscopy as part of Barrett’s oesophagus surveillance during this 3-year trial. All sponge samples will undergo laboratory immunohistochemistry test to evaluate the presence of specific biomarkers such as TFF3, p53 and atypia. These tests are used for risk stratification, which helps determine recommended endoscopic interval for participants.