The first participants have joined a pivotal clinical trial to determine whether a capsule sponge test will become the basis for a new screening programme for oesophageal cancer. The BEST4 Screening trial will investigate whether the test can be used to screen people with heartburn for Barrett’s oesophagus (a condition that can lead to oesophageal cancer), and whether it can reduce the need for cancer treatments and prevent deaths from oesophageal cancer.
Images of the cytosponge courtesy of Cyted
The WIPH Cancer Research UK Cancer Prevention Trials Unit have designed the trial and will analyse the results. Backed by £6.4 million of funding from Cancer Research UK and the National Institute for Health and Care Research, the trial will be led from Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge, and is the last step in a series of clinical trials to see if the capsule sponge test could be offered in the cancer screening programmes of the 4 UK nations.
Over the next three years 120,000 people who regularly take medication for heartburn (the most common symptom for Barrett’s oesophagus) will be recruited to the trial. Invitation will be sent from NHSresearch to eligible people in England and mobile screening vans will be rolled out across England to deliver the tests as part of the trial.
The capsule sponge is a small, coated pill attached to a thread. A patient swallows the pill and when it reaches the stomach the coating dissolves and the sponge inside it expands to the size of a 50p coin. The sponge collects cells from the oesophagus as it is gently pulled out from the stomach by a nurse or GP. The cells are tested for two proteins - Trefoil Factor 3 (TFF3), which is only found in Barrett’s oesophagus, and altered p53 protein, which identifies cells that are starting to grow out of control and become oesophageal cancer.
The 10 minute test can be performed by a nurse, making it a much faster and less expensive test than endoscopy. There are over 9000 new cases of oesophageal cancer in the UK every year, making it the seventh most common cause of UK cancer deaths.
Professor Peter Sasieni, Director of the CRUK Cancer Prevention Trials Unit at Queen Mary University of London and co-principal investigator of the BEST4 trials, said: ‘Most people with Barrett’s oesophagus have heartburn, but most people with heartburn don’t have Barrett’s oesophagus. We have already shown that the capsule sponge can reliably identify people with Barrett’s oesophagus. Now we need to show that using it in a targeted screening programme can help prevent oesophageal cancer and reduce deaths from this disease.’
The BEST4 Screening trial is open to men over age 55 and women over age 65 who are currently taking medication for chronic heartburn. The Endosign test used in the trial is manufactured by Cyted Health, who also carry out the pathology tests on samples obtained by the capsule sponge. Information on how to join the trial can be found at https://best4trial.secureserversites.net/