Diagnosis of oesophageal conditions in patients with reflux including Barrett's oesophagus, Oesophageal cancer, and Eosinophilic oesophagitis. Digestive System
Conditions
Interventions
This study is a single-centre retrospective cohort study using diagnostic samples collected during a routine diagnostic procedure and reported a minimum of 3 months prior to inclusion.
Sponsors
Cyted Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient aged 18 and over 2. Male or female 3. Final pathology report submitted a minimum of 3 months prior to search
Exclusion criteria
Exclusion criteria: 1. Samples submitted less than 3 months prior search 2. Samples that have not yet resulted in a pathology report
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensitivity/specificity for any new biomarker for the given endpoint (1) diagnosis of Barrett's by endoscopy OR (2) risk of cancer) at the end of the study 2. Accuracy as measured against the pathologist's diagnosis for Barrett's diagnosis at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General improvements to our internal laboratory processes for sample testing and reporting to pathologists. Improvements are measured against the current internal standard for sample processing. Each improvement will be evaluated against an appropriate internal sample set, sample size calculations will be performed based on the specific process we address. The final timepoint for all improvement studies will be the end of the study. 2. Identification of biomarkers for other oesophageal conditions including EoE or OSCC measured using a combination of IHC biomarkers, the gold standard for any new biomarker is our pathologist's diagnosis and non-inferiority with our current IHC biomarker tests. Timepoint is at the end of the study. | — |
Countries
England, United Kingdom
Contacts
Public ContactBasirat Afinowi
Outcome results
None listed