We will need some personal details to carry out this out this research. This may include name, NHS number, postcode and date of birth. Personal details may be shared with NHS England and other central UK NHS bodies in order to access and receive necessary information. We will also need to share them with Cyted, the laboratory testing the capsule sponge samples. This is to match the sample back to the person in the trial and their hospital record.
To carry out the research, information will be collected about people in the trial from their local hospital. This will include information about appointments, test results including endoscopy images, medications, conditions and treatments.
To see how surveillance with the capsule sponge test impacts long-term health, we will also collect information from NHS England and other central UK NHS bodies. We will continue to collect this information for 12 years after the trial starts. People who took part in the Heartburn Health Programme will have already agreed to the collection and use of this information.
Capsule sponge samples will be sent to Cyted for testing. Experts at the laboratory treat the sample with special stains and look for signs of cell changes. Signs of cell changes could mean dysplasia is present. If these signs of cell changes are found, an endoscopy is needed to confirm if dysplasia is present or not.
All endoscopy biopsies will be looked at by the usual hospital team. Some endoscopy biopsies will also be sent to Cyted to double check the results.
Results will be shared with the clinical teams at the local hospitals. These will help inform when the next appointment is needed.
In some cases, the University of Cambridge will also perform DNA testing on your samples. They may use your capsule sponge and endoscopy biopsy samples. This is to explore whether DNA tests could give more information about cell changes. As this is very early-stage work, personal results will not be shared back with people in the trial.
All personal details and trial data will be protected in accordance with the Data Protection Act (2018) and UK General Data Protection Regulation. Together, the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust are Data Controllers for the trial. This means that they will make decisions about how the data can be used. Queen Mary University of London and King’s College London are Data Processors. This means that they will be responsible for handling the data safely. King’s College London will be responsible for hosting the BEST4 database.
The KCL Data Protection Officer provides oversight of KCL activities involving the processing of personal data, and can be contacted at info-compliance@kcl.ac.uk. The QMUL Data Protection Officer provides oversight of QMUL activities involving the processing of personal data and can be contact via data-protection@qmul.ac.uk
Only people who need to see personal details to carry out the research will be able to access them. Trial data will be saved with a code number instead.
King’s College London may store personal details with a contracted GDPR compliant third-party storage provider within the UK, where they are the best data storage option. Some employees of the third party will have access to personal details and trial data if needed for their role. They are required to keep your personal details and trial data strictly confidential.
At some point in the future, your data will be transferred from King’s College London to Queen Mary University of London, using secure transfer methods. King’s College London and Queen Mary University of London have a responsibility to keep information collected about you safe and secure. They also have responsibility for ensuring the highest integrity of research data. Specialist teams within King’s College London and Queen Mary University of London continually assess and ensure that data is held in the most appropriate and secure way.
If you would like more information about how your data will be processed in accordance with UK GDPR, please visit the links:
Once the trial has finished, we will share the results here. We will also publish the results in academic journal articles and conferences. If the capsule sponge test works, we hope the test can become part of Barrett’s surveillance soon after the trial ends.
We will only store trial data (not personal details) for up to 5 years once we have finished collecting data.
The University of Cambridge will store the trial data and samples collected indefinitely for future approved research. This will not include personal details like names or contact details.
We may share the coded trial data and samples with researchers outside the University. This could include academic and commercial partners from the UK or other countries.
If you are part of Heartburn Health, the new data and samples collected in this trial will be added to your Heartburn Health record. This includes your capsule sponge samples and endoscopy images. This means the research data will be held as long as the programme exists and researchers can use the data in future approved research.
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