East of England BEST4 trial recruits first participant to monitoring arm

A man from Cambridge is the first to join a clinical trial that could see routine screening for oesophageal cancer introduced into the NHS, potentially halving deaths from this cancer every year.

The capsule sponge, known as the pill-on-a-thread, is a quick and simple test for Barrett’s oesophagus, a condition indicated by a changing of cells in the food pipe which can be a precursor to cancer. Heartburn is a common symptom of Barrett’s oesophagus.

The BEST4 trial, launched at Cambridge University Hospitals NHS Foundation Trust (CUH), is the final step needed to see if use of the capsule sponge can prevent oesophageal cancer when used to screen or monitor those most at risk of the disease. If so, it could become a national screening programme across the NHS.

Around 9,200 people are diagnosed with oesophageal cancer in the UK each year and around 59% of cases are thought to be preventable.

The first stage of the trial, BEST4 Surveillance, is for people already diagnosed with Barrett’s oesophagus. It will look at whether the capsule sponge test could replace endoscopies to monitor their condition.

Participants will receive both screening tests during the trial with results used to assess their risk of developing oesophageal cancer.

The second stage of the trial, BEST4 Screening, opens in the summer and will recruit 120,000 people aged over 55 on long-term treatment for heartburn.

The £6.4million trial is jointly funded by the National Institute for Health and Care Research (NIHR) and Cancer Research UK (CRUK).

Tim’s story

Tim, 49, has had heartburn every night since he was a teenager. He was diagnosed with Barrett’s oesophagus while at university, and he has been monitored ever since.

“Since my diagnosis, I’ve been going for an endoscopy at least once every three years to monitor my oesophagus. It is not pleasant at all.

“Swallowing a capsule sponge is a much better experience and I now get the test before my regular endoscopy appointment.

“Taking part in this study means a lot to me, as my condition was caught before it even became a fully-fledged cancer. Sadly, many others aren’t so lucky. The capsule sponge could help others whose acid reflux is causing something more sinister.”

Preventing oesophageal cancer

The trial builds on decades of research led by Professor Rebecca Fitzgerald, a doctor and researcher at CUH and the University of Cambridge. She and a team of scientists, clinicians and nurses at the Early Cancer Institute, University of Cambridge and CRUK Cambridge Centre, invented and refined the capsule sponge test.

Professor Rebecca Fitzgerald said: “Cases of oesophageal cancer have increased sixfold since the 1990s. On average, only 12% of patients live more than five years after diagnosis. Most don’t realise there’s a problem until they have trouble swallowing - by then it is too late.”

“The capsule sponge, a quick and simple test for Barrett’s oesophagus, could halve the number of deaths from oesophageal cancer every year.”

The pill-on-a-thread

Barrett’s oesophagus is currently identified through endoscopy and a biopsy. It is time-consuming, unpleasant, and quite invasive for patients, as well as being expensive for the healthcare system.

The capsule sponge is a small, easy to swallow capsule on a thread, which contains a sponge. The patient swallows the capsule which dissolves in the stomach and the sponge expands to the size of a 50p coin. The sponge is carefully pulled back up using the string, collecting cells for laboratory testing.

The NIHR and CRUK have funded several successful clinical trials to demonstrate that the test is safe, accurate and can detect 10 times more cases of Barrett’s oesophagus than standard practice.

Dr Helen Macdonald, NIHR Clinical Research Network East of England Chief Operating Officer, said: “We have supported the BEST trials for many years, and it is fantastic to see the launch of the next stage of this groundbreaking study. We are immensely grateful to patients like Tim who volunteer for research studies to help find the best ways to monitor people.”

More information about the BEST4 trial can be found at www.best4trial.org

You can watch the NIHR’s ‘ask the expert’ webinar with Professor Rebecca Fitzgerald on YouTube.

Image Credit: CRUK