Clinical trial · Interventional
Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus
Barrett's Oesophagus Two Yearly Surveillance Versus Endoscopy at Need: a Randomised Controlled Trial to Estimate Effectiveness and Cost-effectiveness Study (BOSS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment. It is not yet known whether endoscopy every 2 years is more effective than endoscopy only as needed in finding esophageal cancer in patients with Barrett esophagus. PURPOSE: This randomized phase III trial is studying endoscopy every 2 years to see how well it works compared with endoscopy only as needed in monitoring patients with Barrett esophagus.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2 yearly endoscopy | Procedure | — | UNRESOLVED |
| comparison of screening methods | Procedure | — | UNRESOLVED |
| diagnostic endoscopic procedure | Procedure | — | UNRESOLVED |
| endoscopic biopsy | Procedure | — | UNRESOLVED |
| endoscopic procedure | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| screening method | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 2 yearly endoscopies
- description
- Two years endoscopies
- interventionNames
- Procedure: 2 yearly endoscopy
- Procedure: comparison of screening methods
- Procedure: diagnostic endoscopic procedure
- Procedure: endoscopic biopsy
- Procedure: endoscopic procedure
- Procedure: quality-of-life assessment
- Procedure: screening method
- type
- EXPERIMENTAL
- label
- endoscopy at need
- description
- Endoscopy only when patient reports symptoms
- interventionNames
- Procedure: 2 yearly endoscopy
- Procedure: comparison of screening methods
- Procedure: diagnostic endoscopic procedure
- Procedure: endoscopic biopsy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed circumferential Barrett metaplasia meeting 1 of the following criteria: * At least 1 cm from the gastro-esophageal junction * At least a 2 cm non-circumferential tongue of Barrett metaplasia * Undergone endoscopy within the last 2 years to confirm Barrett metaplasia and exclude high-grade dysplasia and carcinoma * No known high-grade dysplasia or carcinoma PATIENT CHARACTERISTICS: * Resident of the United Kingdom * Informed of the risk of Barrett esophagus developing into esophageal cancer, either at the visit when the invitation letter is issued or on a documented previous occasion * Able to undergo endoscopy * No medical conditions that would make endoscopy difficult or hazardous PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (1)
- DERIVEDOld O, Jankowski J, Attwood S, Stokes C, Kendall C, Rasdell C, Zimmermann A, Massa MS, Love S, Sanders S, Deidda M, Briggs A, Hapeshi J, Foy C, Moayyedi P, Barr H; BOSS Trial Team. Barrett's Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS): A Randomized Controlled Trial. Gastroenterology. 2025 Nov;169(6):1233-1243.e8. doi: 10.1053/j.gastro.2025.03.021. Epub 2025 Apr 1. PMID 40180292