First participant recruited on landmark cancer screening trial

The first participant has been recruited on a pivotal trial of a “pill-on-a-thread” test, which will decide if it becomes a new screening programme for oesophageal cancer.

The BEST4 Screening trial will find out if the capsule sponge test could be used to screen people with heartburn for Barrett’s oesophagus – a condition that can lead to oesophageal cancer.

The trial is co-funded by NIHR and Cancer Research UK. It will be led from Cambridge University Hospitals NHS Foundation Trust (CUH) and the University of Cambridge.

Innovative trial

The test takes 10 minutes to do and can be done by a nurse. This makes it much faster and less expensive than endoscopy. The trial will find out if the test can reduce the need for cancer treatments, and prevent deaths from the disease. The trial showcases UK science and innovation. It is the last step in a series of clinical trials to see if the test could be offered in UK cancer screening programmes.

Over the next 3 years, the team will recruit 120,000 people who regularly take medication for heartburn. Heartburn is the most common symptom for Barrett’s oesophagus. The condition, a precursor condition to oesophageal cancer, is where cells in the food pipe start to grow abnormally.

Invitations to join the trial will be sent by text message from NHSResearch. This will encourage as many eligible people as possible to take part in England. Participants will be asked to join a new platform called Heartburn Health. The platform enables people to take part in clinical trials in heartburn-linked cancers. Mobile screening vans will be rolled out across England to deliver the tests as part of the trial.

There are around 9,300 new cases of oesophageal cancer in the UK every year. Oesophageal cancer is the seventh most common cause of cancer death in the UK. There are around 22 deaths a day from the disease.

Paul Anderson, 59, a stock controller from St Neots, Cambridgeshire, is one of the first participants to join the trial. He said: “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.”

Building on previous research

The capsule sponge starts off as a small, coated pill attached to a thread. When a patient swallows the pill and 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 sent for testing for two proteins called Trefoil Factor 3 (TFF3), which is only found in Barrett’s oesophagus, and altered p53 protein, which identifies cells which are starting to grow out of control and become oesophageal cancer. 

Cancer Research UK funded previous clinical trials demonstrating the test is safe and accurate. The BEST3 trial, which was supported by the NIHR, showed the test picks up 10 times more cases of Barrett’s oesophagus in people with chronic heartburn, compared to endoscopy. 
To date, over 24,000 capsule sponge tests have been performed in pilot programmes, helping to reduce diagnostic backlogs in endoscopy and NHS pathology.

‘Transforming lives’

Professor Rebecca Fitzgerald, is Director of the Early Cancer Institute at the University of Cambridge, and the trial’s co-principal investigator. She 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.”

Scientific Director for NIHR Programmes, Professor Danny McAuley, said: “The capsule sponge is an innovative device that has already shown great potential to prevent deaths from oesophageal cancer.

“It’s a great milestone to see the first patient recruited on this pioneering NIHR and CRUK funded trial which in future we hope can lead to routine screening for this deadly disease.

“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."

Minister for Public Health and Prevention, Andrew Gwynne, 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.

"As part of our 10 Year Health Plan to radically reform our broken NHS, we are committed to fighting cancer on all fronts, and ensuring patients have access to cutting edge, government-funded research.”

The Cancer Research UK Cancer Prevention Trials Unit at Queen Mary, University of London is designing the trial and analysing results from it. The trial is open to men over the age of 55 and women over the age of 65 who are currently taking medication for chronic heartburn. 

The NIHR funding is through our Health Technology Assessment (HTA) Programme. 

BEST4 is supported by NIHR’s Research Delivery Network (RDN), which helped secure the mobile screening vans to bring the research into the community. 

The RDN (formerly the Clinical Research Network) also supported BEST3 through the recruitment of patients, the onboarding of GP practices and the training of research nurses to deliver the novel pill-on-a-string test.

Read more about the study on its project page.