Cancer Research UK and the National Institute for Health and Care Research are providing £6.4 million for testing of the Cytosponge-TFF3 pioneered by Professor Rebecca Fitzgerald and her team at the University of Cambridge.
Previous studies showed the Cytosponge detected 10 times more cases of Barrett’s oesophagus compared with routine GP care*.
The new trial, BEST4, will explore 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 endoscopy, an invasive hospital procedure for which there is a major backlog caused by the 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 Fitzgerald will lead the trial alongside Professor Peter Sasieni and his team from King’s College London.
The Cytosponge begins as a pill on a string. It is swallowed by a patient and when it reaches the stomach the coating dissolves. This allows 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. As the sponge comes up it collects cells from the oesophagus for lab analysis.
“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.”
Adapting to the pandemic
During the height of the pandemic patients were not being seen for routine gastroscopy. It was decided to rapidly implement use of the Cytosponge test because it has a low aerosol generation and needs only one person to carry out the procedure.
Irene Debiram-Beecham led on the implementation and at the Royal College of Nursing’s annual Nursing Awards she was highly commended in the Excellence in Cancer Research Nursing Award category. The award is sponsored by Cancer Research UK and the only one in the UK to recognise research nurses working on cancer trials and studies.
“As a research nurse, it makes me proud to see something I’ve been working on for many years has finally made it into clinical practice.”
* Fitzgerald, R. C., et al. A pragmatic randomised, controlled trial of an offer of Cytosponge-TFF3 test compared with usual care to identify Barrett’s oesophagus in primary care. The Lancet, 2020