Biomarker improvement and development in non-endoscopic samples

• Research type

  Research Study

• Full title

  Biomarker development to improve diagnostic accuracy for Barrett’s oesophagus, oesophageal cancer and other oesophageal diseases in non-endoscopic samples

• IRAS ID

  322308

• Contact name

  Sarah Killcoyne

• Contact email

  sarah.killcoyne@cyted.ai

• Sponsor organisation

  Cyted Ltd

• Clinicaltrials.gov Identifier

  12685, HTA

• Duration of Study in the UK

  2 years, 11 months, 31 days

• Research summary

  In the past two years Cyted has provided more than 10,000 non-endoscopic based tests for Barrett’s oesophagus and Oesophageal adenocarcinoma. These tests have enabled NHS Trusts to address the endoscopic backlog created during COVID.

  Cyted’s current test relies on a pathologist reading a standard haematoxylin and eosin (H&E) stained slide alongside a slide-based antibody stain (TFF3) to diagnose Barrett’s, and a separate slide-based antibody stain (P53) to identify patients at who are at a high risk of cancer.

  We aim to improve these tests, ensuring that patients continue to be provided the best information available regarding their personal disease risk. This includes expanding our ability to test for Oesophageal squamous cell carcinoma (OSCC) and other oesophageal diseases such as Eosinophilic oesophagitis (EoE).

  We will do this through:
  - Improving the accuracy of our existing artificial intelligence (AI) platform with the inclusion of additional slide images from our diagnostic archive
  - Develop additional biomarkers to supplement the existing slide-based stains (i.e. TFF3, P53) for diagnosis and risk stratification in Barrett’s screening and surveillance samples
  - Identify diagnostic biomarkers for OSCC and EoE

  Improvements to these diagnostic tests will also enable improvements in our pathology reporting to NHS Trusts through increased accuracy for cancer risk, and screening for other diseases (i.e. EoE) that are currently only available through endoscopic sampling.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  22/SC/0470

• Date of REC Opinion

  5 Dec 2022

• REC opinion

  Favourable Opinion