Oesophageal dysplasia Digestive System
Conditions
Interventions
This study aims to collect endoscopic reporting for Barrett's patients who were previously tested using the capsule sponge and identified as having positive biomarkers for possible dysplasia. These e
Sponsors
Cyted Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cases: 1. 18 years old or over 2. Male or Female 3. Previously diagnosed with Barrett’s oesophagus 4. Capsule sponge test performed after 1 June 2021 with a positive p53 and/or positive atypia biomarker result 5. Endoscopic biopsy with pathology performed subsequent to capsule sponge Controls: 1. 18 years old or over 2. Male or Female 3. Previously diagnosed with Barrett’s oesophagus 4. Capsule sponge test performed after 1 January 2022 with a negative p53 and negative atypia biomarker result 5. Endoscopic biopsy with pathology performed subsequent to capsule sponge with non-dysplastic pathology observed
Exclusion criteria
Exclusion criteria: 1. Under 18 years old 2. Barrett’s diagnosis unconfirmed 3. Capsule sponge biomarker test missing p53 and atypia results 4. Missing endoscopic pathology results 5. Patient deceased
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured using patient records: 1. Capsule sponge biomarkers for dysplasia (p53/atypia) 2. Follow-up endoscopic histopathology for Barrett's oesophagus (non-dysplastic, indeterminate, low-grade, high-grade, intramucosal adenocarcinoma) 3. Novel whole-genome molecular targets (proprietary currently) evaluated using an algorithm to provide a probability estimation for likelihood of dysplasia/cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactSamantha Roberts
Outcome results
None listed