Barrett's oesophagus Digestive System
Conditions
Interventions
Current interventions as of 27/07/2026:
The BEST4 Screening study aims to recruit 120,000 people (men aged 55-79 years and women aged 65-79 years) with heartburn over a two-and-a-half-year period. Th
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
55 Years to 79 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 07/10/2025: Heartburn Health Programme: 1. Have given electronic informed consent to participate 2. UK resident 3. Males aged 55 - 79 years and Females aged 65 - 79 years (sex at birth) 4. Have a mobile phone number 5. Patient reported symptoms and/or use medication for heartburn, acid reflux and indigestion. Screening Trial: 1. Meet same criteria as Heartburn Health 2. Patient reported regular symptoms of heartburn, acid reflux and indigestion in the last 6 months AND/OR 3. Confirmed regular use of a prescription or over the counter acid-suppressant medication in the last 6 months 4. Express interest in a capsule sponge test _____ Previous inclusion criteria: Heartburn Health Programme: 1. Have given electronic informed consent to participate 2. Males aged 55 - 79 years and Females aged 65 - 79 years (sex at birth) 3. Have a mobile phone number 4. Self-confirmed symptoms of heartburn, acid reflux and indigestion Screening Trial: 5. Meet same criteria as Heartburn Health 6. Self-confirmed regular use (biweekly) of a prescription or over-the-counter acid-suppressant medication in the last 6 months
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 07/10/2025: Screening Trial: 1. Patient reported difficulty swallowing pills 2. Patient reported previous diagnosis of BO 3. Patient reported upper GI endoscopy in the last 3 years 4. Patient reported Cytosponge/capsule sponge procedure in the last 3 years 5. Patient reported diagnosis of oesophageal cancer 6. Patient reported prior surgical intervention to the oesophagus or upper stomach _____ Previous exclusion criteria: Screening Trial: 1. Patient-reported a previous diagnosis of BO confirmed on histology 2. Patient-reported upper GI endoscopy in the last 5 years 3. Patient-reported Cytosponge/Capsule Sponge procedure in the last 5 years 4. Meet the guidelines for an urgent endoscopy referral according to NICE guidelines (dyspepsia with acute GI bleed, dyspepsia that fails to respond to PPI or H2R antagonist with negative Helicobacter Pylori test, unintentional weight loss, persistent vomiting, iron deficiency anaemia, epigastric mass, suspicious barium meal indicating risk of cancer) 5. Recorded diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour (T2 staging and above), or symptoms of dysphagia 6. Difficulty in swallowing due to a known cerebrovascular accident or neurological disorder 7. Recorded oesophageal varices, cirrhosis of the liver, portal hypertension 8. Received prior endoscopic (photodynamic therapy or radiofrequency ablation) or surgical intervention to the oesophagus 9. Inability to temporarily discontinue anti-thrombotic medication prior to the procedure as per clinical JAG guidelines 10. Known pregnancy 11. Lack of capacity to provide informed consent 12. Procedural: Having eaten or drank within the last 4 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Diagnosis of stage II+ oesophageal adenocarcinoma, ascertained from the baseline endoscopy (intervention arm, TFF3 positive only) and from National Cancer Registration and Analysis Service (NCRAS) data (years 1-12) 2. Deaths from oesophageal adenocarcinoma, including those arising at the gastro-oesophageal junction, obtained from National Cancer Registration and Analysis Service (NCRAS) data (years 1-12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Deaths from oesophagogastric cancer, obtained from National Cancer Registration and Analysis Service (NCRAS) data (years 1-12) 2. Diagnosis of dysplastic BE or intramucosal OAC, ascertained from the baseline endoscopy (intervention arm, TFF3 positive only) at 6, 7.5, and 12 years 3. Booking a screening appointment, obtained from Case Report Forms (intervention arm, TFF3 positive only) at 3 years (end of active recruitment) 4. Attendance at a screening appointment, obtained from Case Report Forms (intervention arm, TFF3 positive only) at 3 years (end of active recruitment) 5. Ability to swallow the capsule sponge in those who attend a screening appointment, obtained from Case Report Forms (intervention arm, TFF3 positive only) at 3 years (end of active recruitment) 6. Attendance at endoscopy appointment in those referred for endoscopy following a positive screen, obtained from Case Report Forms at 3 years (end of active recruitment) | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed