Major trial of sponge test aims to prevent oesophageal cancer deaths
The study has been hailed as the ‘pinnacle of many years of painstaking research’ by experts.
A major trial to determine if an innovative 10-minute sponge test should be used to screen people with heartburn for oesophageal cancer has welcomed its first patients.
The capsule sponge test involves patients swallowing a dissolvable pill on a string, which releases a sponge the size of a 50p coin to collect cells from the oesophagus as it is retrieved.
It picks up abnormalities that form as part of a condition known as Barrett’s oesophagus, which makes a person more likely to develop oesophageal cancer.
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
It is hoped that using the test to screen for the disease could save lives and reduce the need for “labour-intensive” endoscopy – a camera down the throat – which is currently the “gold standard” to diagnose and treat this type of cancer.
The study – known as the Best4 Screening trial – has been hailed as the “pinnacle of many years of painstaking research” by experts.
It will aim to recruit 120,000 people over the next three years.
People who regularly take medication for heartburn will be invited to join with a text message from NHS research.
Professor Rebecca Fitzgerald, director of the Early Cancer Institute at the University of Cambridge, invented the sponge test and is co-principal investigator of the Best4 trial.
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.”
As part of the trial, patients will visit mobile vans for the 10-minute test, where they will be given a small, coated pill attached to a thread.
When this reaches the stomach, the coating dissolves and releases a small sponge.
This collects cells from the oesophagus as it is pulled from the stomach and will then be sent to be tested for two proteins; 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.
Prof Fitzgerald added: “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.”
A previous trial – Best3 – found the 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, is one of the first patients to join Best4.
The stock controller from St Neots started getting acid reflux a decade ago and has been on medication to manage it ever since.
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.”
Oesophageal cancer affects about 9,300 people a year, according to Cancer Research UK.
Around 59% 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
Professor Peter Sasieni, director of the Cancer Research UK Cancer Prevention Trials Unit at Queen Mary University of London, said: “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.”
Best4 has been backed by ?6.4 million from Cancer Research UK and the National Institute for Health and Care Research (NIHR).
Cancer Research UK chief executive Michelle Mitchell said: “Around 59% 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.”
Ms Mitchell described the sponge test as one of the “most exciting early detection tools to emerge in recent years”.
“It’s a remarkable invention by Professor Fitzgerald and her team, and previous trials have shown how powerful it can be in identifying cancer earlier,” she added.
“Cancer Research UK is proud to be supporting this landmark clinical trial, bringing the capsule sponge test into the community and offering it to a much wider group of patients. After many decades of research, we’re on the cusp of transforming oesophageal cancer diagnosis forever.”