Trial Design

The Screening Trial is a randomised controlled trial aiming to recruit 120,000 people with heartburn over a three-year period through Heartburn Health. Men aged 55-79 and women aged 65-79 taking regular acid-suppressant medications, living in certain areas in the UK and with no history of Barrett’s or oesophageal cancer may be selected from the programme.

The study will compare standard care (N=80,000) with capsule sponge test screening (N=40,000). Participants randomised to the screening arm will be invited by text message to have the test at mobile units in the community.

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 suspected upper gastrointestinal tract cancer referrals.

Participant Results  

Negative results – no further GP action required   

Patients will receive negative results via a text message. GPs will NOT be notified of patient involvement or the results.

Negative results, other relative clinical findings – GP review required   

GPs will be informed of other clinical findings. The clinical 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 – no GP action required   

Patients will be notified by text message and invited to book another test. GPs will NOT be notified.

Positive results, endoscopy – no GP action required

Patients will be contacted by the clinical study team to discuss their results and they will be referred for an endoscopy to be completed within 8 (+4 weeks) at the local participating secondary care site. The referral will be made by the clinical study team via ERS. GP will NOT be notified of patient involvement or capsule sponge test result.

Positive results, endoscopy via the Faster Diagnosis Standard – GP notification

Patients will be contacted by the clinical study team to discuss their results and referred for an endoscopy via the Faster Diagnosis Standard (FDS) pathway at the local participating secondary care site. The referral will be made by the clinical study team via ERS. GP WILL be notified.

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.