New trial will determine if Cambridge-invented test will be new oesophageal cancer screening tool

A key clinical trial to determine if the ‘pill-on-a-thread’ test invented in Cambridge becomes a new screening tool for oesophageal cancer has welcomed its first participants.

Over the next three years, the BEST4 Screening trial will recruit 120,000 people who regularly take medication for heartburn, which is the most common symptom for Barrett’s oesophagus.

This is a precursor condition to oesophageal cancer, in which cells in the food pipe grow abnormally.

The trial will see if the new capsule sponge test can be used to screen people with heartburn for Barrett’s oesophagus and, in turn, reduce the need for cancer treatments and prevent deaths from oesophageal cancer.

The test takes 10 minutes and can be administered by a nurse, making it much quicker and cheaper than endoscopy.

A series of clinical trials has already been held, as the Cambridge Independent has been reported, but this new trial will be pivotal in determining whether the capsule sponge test can be offered in cancer screening programmes across the four UK nations.

It follows decades of research by Professor Rebecca Fitzgerald and a team of scientists, clinicians and nurses at the Early Cancer Institute, University of Cambridge, and Cancer Research UK Cambridge Centre, who invented and refined the test.

It involves a patient swallowing a small, coated pill attached to a thread. When the pill reaches the stomach, the coating dissolves and the sponge inside expands to the size of a 50p coin.

As it is gently pulled out from the stomach by a nurse or GP, the sponge collects cells from the oesophagus.

The cells are sent for testing for two proteins called Trefoil Factor 3 (TFF3), 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.

Prof Fitzgerald, director of the Early Cancer Institute and co-principal investigator of the BEST4 trials, said: “The capsule sponge is changing how we detect Barrett’s oesophagus and oesophageal cancer. Catching it earlier can save lives by reducing the need for chemotherapy and surgery to remove the oesophagus.

“The BEST4 Screening trial is the pinnacle of many years of painstaking research, which has demonstrated that the capsule sponge can reliably identify Barrett’s oesophagus. Thousands of people have already benefited in trials and pilot programmes, and now we’re taking the test to the next level to see if we could offer this to everyone with heartburn.

“The BEST4 Screening trial could fundamentally transform the lives of people affected by oesophageal cancer by providing the crucial evidence needed to make it a viable screening programme, rolled out to every part of the UK.”

Text messages from NHSresearch will be sent out inviting as many eligible people as possible in the UK to join the trial.

Participants will be asked to join Heartburn Health - a new platform for clinical trials in heartburn-linked cancers. Mobile screening vans will be used across England to deliver the tests.

Around 9,300 new cases of oesophageal cancer are detected every year in the UK, according to Cancer Research UK.

It is the seventh most common cause of cancer death in the UK, with around 22 deaths a day from the disease.

The trial is supported by £6.4million of funding from Cancer Research UK and the National Institute for Health and Care Research (NIHR) and will be led from Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge, with the Cancer Research UK Cancer Prevention Trials Unit at Queen Mary University of London (QMUL) designing the trial and analysing results from it.

Prof Peter Sasieni, Director of the Cancer Research UK Cancer Prevention Trials Unit at QMUL 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.”

Endoscopy is currently used to diagnose Barrett’s oesophagus and oesophageal cancer.

But the new test has already been piloted in health services in England, Scotland and Northern Ireland for patients on waiting lists for endoscopy because they have long-term heartburn or have already been diagnosed with Barrett’s oesophagus.

More than 24,000 capsule sponge tests have already been performed in pilot programmes, helping to reduce diagnostic backlogs in endoscopy and NHS pathology.

The previous BEST3 clinical trial showed that the capsule sponge test picks up 10 times more cases of Barrett’s oesophagus in people with chronic heartburn compared to routine GP care.

Paul Anderson, 59, a stock controller from St Neots, was one of the first participants to join the BEST4 Screening trial in Cambridgeshire and said: “I first experienced acid reflux 10 years ago and I was referred for endoscopy to get it checked out. I’ve been on medication for heartburn ever since to manage it.

“I’d never been on a clinical trial before, but when the invitation came for this one, I felt I had to sign up as the acid reflux had flared back up again. I’m hoping that it may give me some more insight into my chronic heartburn, as well as helping people who may have similar concerns about their health.

“I’m hopeful that playing my small part in this worthy cause will help others to get checked out earlier.”

Michelle Mitchell, chief executive of Cancer Research UK,said: “Around 59 per cent of all oesophageal cancer cases are preventable. Yet endoscopy, the gold standard for diagnosing and treating this cancer, is labour-intensive and not practical for a population screening programme.

“Backed by funding from Cancer Research UK, the capsule sponge has become one of the most exciting early detection tools to emerge in recent years. After many decades of research, we’re on the cusp of transforming oesophageal cancer diagnosis forever.”

Andrew Gwynne, minister for public health and prevention, said: “This trial is a shining example of how we can harness the power of technology to improve patient experience and speed up diagnosis.

"This innovation has the potential to allow us to perform lifesaving screenings quicker and cheaper, freeing up vital NHS resources.”

Professor Danny McAuley: scientific director for NIHR Programmes, said: “Thousands of people are needed to join this trial, and we encourage people to sign up as participants. This important research will help benefit patients, and inform those who plan and deliver NHS services of how best to test for the disease."

The test is also being commercialised by Cyted.

Find out more on the BEST4 website at https://best4trial.secureserversites.net/ or by emailing best4.trial@nhs.net. You can also sign up to the NIHR’s Be Part of Research service at bepartofresearch.uk to take part in clinical research.