Biomarker improvement and development in non-endoscopic samples
| ISRCTN | ISRCTN15151491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15151491 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 322308 |
| Protocol serial number | IRAS 322308 |
| Sponsor | Cyted Ltd |
| Funder | Cyted Ltd |
- Submission date
- 20/12/2022
- Registration date
- 31/01/2023
- Last edited
- 31/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
In the past two years, Cyted Ltd (UK) 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 with 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).
Who can participate?
Samples collected from patients with Barrett’s oesophagus and Oesophageal adenocarcinoma during a routine diagnostic procedure
What does the study involve?
This study intends to:
1. Improve the accuracy of our existing artificial intelligence platform with the inclusion of additional slide images from our diagnostic archive
2. 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.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Cyted Ltd (UK)
When is the study starting and how long is it expected to run for?
November 2022 to December 2025
Who is funding the study?
Cyted Ltd (UK)
Who is the main contact?
Dr Sarah Killcoyne (Principal investigator), sarah.killcoyne@cyted.ai (UK)
Ms Basirat Afinowi, basirat.afinowi@cyted.ai (UK)
Contact information
Principal investigator
22 Station Road
Cambridge
CB1 2JD
United Kingdom
 ORCID ID |
0000-0003-3686-6167 |
|---|---|
| Phone | +44 (0)1480 453 437 |
| sarah.killcoyne@cyted.ai |
Public
22 Station Road
Cambridge
CB1 2JD
United Kingdom
| Phone | +44 (0)1480 453 437 |
|---|---|
| basirat.afinowi@cyted.ai |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre retrospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Biomarker improvement and development in non-endoscopic samples within the Cyted diagnostic pathway |
| Study objectives | This study’s primary objective is to improve our available biomarker tests to ensure continued high-quality diagnostic information is provided to patients. This will be achieved by identifying additional biomarkers that can be used in addition to, or as an alternative to the current TFF3/P53/atypia slide-based stains. |
| Ethics approval(s) | Approved 05/12/2022, South Central - Berkshire B Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +442071048276; berkshireb.rec@hra.nhs.uk), ref: 22/SC/0470 |
| Health condition(s) or problem(s) studied | Diagnosis of oesophageal conditions in patients with reflux including Barrett's oesophagus, Oesophageal cancer, and Eosinophilic oesophagitis. |
| Intervention | 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. A targeted set of molecular tests will be run to assess sufficiency for the existence of specific cell types relating to disease, sensitivity/specificity analysis in comparison to existing methods and assess what the normal/healthy range is in patients without cancer. Image-based machine learning methods will include analysis of cellular mixtures and ratios of cell types in different cohorts and an accuracy assessment for our internal quality control procedures. |
| Intervention type | Other |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 10000 |
| Key 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 |
| Key exclusion criteria | 1. Samples submitted less than 3 months prior search 2. Samples that have not yet resulted in a pathology report |
| Date of first enrolment | 01/01/2023 |
| Date of final enrolment | 01/12/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cambridge
CB1 2JD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | Summary datasets generated during and/or analysed during the current study will be published as a supplement to the results publication. Individual results will not be made available to ensure anonymisation is preserved. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.0 | 11/11/2022 | 22/12/2022 | No | No |
Additional files
- 42930 Protocol v1.0 11Nov2022.pdf
- Protocol file
Editorial Notes
22/12/2022: Trial's existence confirmed by Health Research Authority (HRA) (UK).
