Published: 28 April 2022
NIHR has co-funded a new £6.4m trial which could pave the way for a test to be established as a routine screening programme to detect Barrett’s oesophagus – a condition that can lead to oesophageal cancer.
The BEST-4 trial, funded in partnership with Cancer Research UK is testing the Cytosponge-TFF3 (‘sponge on a string’) - a device pioneered by researchers at the University of Cambridge.
Previous studies showed Cytosponge detected 10 times more cases of Barrett’s oesophagus compared with routine GP care. Now researchers are exploring if the Cytosponge can prevent deaths from oesophageal cancer when offered as a screening test to people on long-term medication for heartburn – one of the most common Barrett's oesophagus symptoms.
Researchers will also investigate if the Cytosponge, coupled with additional lab biomarker tests, can be used to monitor people already diagnosed with Barrett’s oesophagus instead of an endoscopy – an invasive hospital procedure which there is a major backlog caused by the COVID-19 pandemic.
It is anticipated the trial team will begin setting up sites in autumn, with 120,000 patients to take part over 14 years. Those involved will be randomised to different groups and a third of those will receive the Cytosponge, a quick and simple test that can be carried out by a GP.
Professor Rebecca Fitzgerald from the University of Cambridge, is leading the trial with Professor Peter Sasieni from King’s College London.
Professor Fitzgerald said: “The BEST-4 trial is an exciting opportunity to take our work on the Cytosponge-TFF3 to the next level and see whether this test not only detects more cases, but also saves lives from cancer of the oesophagus. It will be a big piece of work, but it’s timely given the push from the NHS leadership, the Life Sciences Industrial Strategy and Cancer Research UK to detect cancers earlier in order to improve outcomes for patients.”
Cytosponge begins as a pill on a string, which is swallowed by patients. When it reaches the stomach the coating dissolves, allowing the pill to expand into a small sponge, about the size of a 50p coin. The sponge is pulled back out of the stomach by a nurse, and as it comes up it collects cells from the oesophagus for lab analysis.
Dr Iain Foulkes, executive director of research and innovation for Cancer Research UK, said: “There are 9,200 people diagnosed with oesophageal cancer in the UK every year and the Cytosponge will mean they can benefit from kinder treatment options if their cancer is caught at a much earlier stage, hopefully helping to boost survival rates at the same time.”
The study is funded by NIHR’s Health Technology Assessment (HTA) Programme and supported by the Clinical Research Network (CRN).