Developing new tests to detect oesophageal dysplasia in patients using historic capsule sponge data

Plain English summary of protocol

Background and study aims
Oesophageal cancer has seen a rapid rise in the U.K. since the 1990’s with little improvement in the overall 5-year survival rate that continues to be less than 20%.
The pre-malignant tissue called Barrett’s oesophagus provides an opportunity for early detection of cancer through monitoring of patients identified to have this condition.
Barrett’s identification and monitoring presents additional complexities to the determination of risk. Only 0.3% of patients with a non-dysplastic Barrett’s diagnosis will progress to an early cancer each year. Current clinical surveillance strategies for patients rely on regular endoscopic biopsies with histopathology, creating a significant burden on patients who are unlikely to develop cancer and specialists spend significant time and resources on each endoscopy. Despite this a Barrett’s diagnosis is the best opportunity for early detection of this cancer.
Since 2020 patients at specific NHS sites in Scotland who were diagnosed with Barrett’s have been offered an oesophageal capsule sponge test (i.e. Cytosponge™ or EndoSign®) for surveillance of previously non-dysplastic Barrett’s. Patients with a positive test on the capsule sponge are recommended an urgent endoscopic investigation to look for dysplasia or early cancer. Patients with a negative test are recommended ongoing surveillance by capsule sponge or alternating endoscopy.
The Research & Development team at Cyted Health Ltd has developed novel molecular biomarker targets for diagnosis of Barrett’s and dysplasia using a genomic methylation sequencing based approach. This offers a quantitative and objective diagnostic tool that will decrease the burden on histopathology by prioritising patients for investigation.

Who can participate?
Patients over 18 years old and previously diagnosed with Barrett's oesophagus

What does the study involve?
The NHS site will retrospectively consent patients who meet the criteria required and will share their endoscopy tissue blocks and data. The information will assist the Cyted health R&D team to develop a model that will provide a clear read out as to whether the patient has dysplasia or not.

What are the possible benefits and risks of participating?
This study is to validate a set of quantitative molecular biomarkers for detecting dysplasia or cancer using the capsule sponge test in patients known to have Barrett’s oesophagus. This will allow patients in surveillance for Barrett’s to be monitored using a less invasive test while ensuring that patients who show signs of early cancer to access endoscopic evaluation urgently.
In this study, patients will only be asked to share follow-up endoscopic data to enable concordance measures to be evaluated between the molecular test and the gold standard of endoscopy with histopathology.
The primary risk of this project is the sharing of data and biopsy samples. Cyted Health Ltd uses secure systems, and pseudonymisation of all patient data to mitigate these risks.

Where is the study run from?
Cyted Ltd (UK)

When is the study starting and how long is it expected to run for?
March 2024 to September 2027

Who is funding the study?
Cyted Ltd (UK)

Who is the main contact?
Samantha Roberts, s.roberts@cytedhealth.com

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Scotland
• United Kingdom

Study participating centre

Sponsor information

Funders

Funder type

Industry

Results and Publications

Study outputs

Additional files

45766 DysplasiaBAR Protocol V1.0 18.02.2024.pdf

Editorial Notes

13/11/2024: The recruitment start date was changed from 01/11/2024 to 20/09/2024.
10/07/2024: Trial's existence confirmed by East Midlands - Derby Research Ethics Committee.