non-dysplastic Barrett's oesophagus Digestive System
Conditions
Interventions
- (Cohort 1) People who have participated in the BEST4 Screening Trial and have subsequently been diagnosed with NDBO will be invited by their local hospital team. The research team will flag potentia
Sponsors
Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort1 Have participated in the BEST4 Screening study where;TFF3 positive on capsule sponge and as part of confirmatory endoscopy at participating secondary care site were diagnosed with NDBO defined as endoscopic evidence of BO at least 2cm (Prague C> = 0 and M> = 2) and intestinal metaplasia with no dysplasia in biopsies taken according to the Seattle protocol. OR Cohort 2 1. Be aged > = 18years 2. Have a known diagnosis of NDBO, defined as endoscopic evidence of BO at least 2 cm (Prague C> = 0 and M> = 2) and intestinal metaplasia with no dysplasia in biopsies taken at the previous endoscopy 3. Be presenting for routine endoscopic surveillance at a participating secondary care site.
Exclusion criteria
Exclusion criteria: 1. Recorded high grade dysplasia on last endoscopy (note, low grade dysplasia or indefinite for dysplasia previous to last endoscopy is not an exclusion) 2. Recorded diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour, or symptoms of dysphagia (food sticking) 3. Received prior endoscopic (photodynamic therapy, endoscopic resection or radiofrequency ablation) or surgical intervention to the oesophagus (note, this does not include previous fundoplication treatment) 4. Recorded oesophageal varices, cirrhosis of the liver (including compensated Child A cirrhosis) 5. Unable to follow device anti-coagulation medication guidance 6. Difficulty in swallowing due to a known cerebrovascular accident or neurological disorder 7. Known pregnancy 8. Lack capacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Risk of Barrett’s neoplasia (Pilonis risk score) assessed using a biomarker panel from the baseline capsule sponge (comprising p53 and atypia) together with clinical characteristics (age, sex, length of Barrett’s). 2. Diagnosis of prevalent Barrett’s oesophagus, ascertained from the baseline endoscopy. 3. Diagnosis of incident Barrett’s oesophagus, ascertained from follow-up endoscopy during the 3 year study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnosis of prevalent Barrett’s neoplasia, high grade dysplasia or oesophageal adenocarcinoma, ascertained from the baseline endoscopy. 2. Diagnosis of incident Barrett’s neoplasia, high grade dysplasia or oesophageal adenocarcinoma, ascertained from follow-up endoscopy (3m, 18m or 36m) during the 3 year study period. 3. Capsule sponge sample assessed as inadequate (at baseline, 18m or 36m) during the 3 year study period. 4. Presence of atypia, atypia of uncertain significance or aberrant p53 on capsule sponge samples (at baseline, 18m or 36m) during the 3 year study period. 5. Diagnosis of incident oesophageal adenocarcinoma, years 4-12, to be obtained from National Cancer Registration and Analysis Service (NCRAS) data. 6. Stage of diagnosis with incident oesophageal adenocarcinoma will be obtained from participants medical records during the 3 year study period and from National Cancer Registration and Analysis Service (NCRAS) data for years 4-12. 7. Deaths from oesophageal adenocarcinoma will be obtained from participants medical records during the 3 year study period and from National Cancer Registration and Analysis Service (NCRAS) data for years 4-12. 8. Endoscopic treatment for either dysplastic Barrett’s oesophagus or intramucosal oesophageal adenocarcinoma over 12 years (from the start of the study), will be identified from National Cancer Registration and Analysis Service (NCRAS) data. | — |
Countries
England, United Kingdom
Outcome results
None listed