Taking part involves having capsule sponge tests alongside regular surveillance endoscopies. Before taking part, each person will have time to discuss the trial in detail and will be asked to sign a consent form.
People will be invited to have the test before their next surveillance endoscopy. The trial team will arrange this appointment at their local hospital on the same day as their surveillance endoscopy. People who took part in the BEST4 Screening Trial won’t need these first tests. We will use the results from their Screening Trial tests instead.
The local clinical team will decide when to invite each person back. This will be based on the capsule sponge and endoscopy results, as well as personal factors like age and sex. Everyone will be invited to have another capsule sponge test and endoscopy in 3 years. Some people may also be offered a repeat endoscopy in 3 months’ time, and/or a capsule sponge test in 18 months’ time. If any capsule sponge samples do not contain enough cells to give a clear result, it may have to be repeated.
If at any point the endoscopy shows dysplasia or early cancer, further trial related tests will stop. All recommended care will be offered by the participant’s doctor, including any treatment if needed. Participants will receive all the care they would usually receive while taking part in the trial. The capsule sponge test will be in addition to usual care. After the trial, regular surveillance will continue.
All capsule sponge tests and endoscopies for people in the trial will be arranged by the local clinical teams. Appointments can be rearranged by contacting the local clinical team using the contact details in the participant information sheet.
Results of both tests will be shared together. This could be by letter, text message or phone depending on local practice. All results will be explained by the doctor or a member of the hospital clinical team after each test.
Anyone in the trial can stop taking part at any time without giving a reason. Stopping will not impact a person’s care or legal rights.
To stop taking part, people in the trial can contact their local trial team using the details in their participant information sheet.
We need to manage the data in specific ways for the research to be reliable. This means if someone stops taking part, information already collected will be kept. People in the trial will not be able to see or change the data held about them. If someone loses the ability to consent after joining the trial, we will keep the information about them we already have.
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