‘Pill-on-a-thread’ trial aims to transform oesophageal cancer screening
University of Cambridge move
A groundbreaking clinical trial, which could lead to a new screening programme for oesophageal cancer, has inducted its first participants. The BEST4 Screening trial is testing a novel pill-on-a-thread device designed to detect Barrett’s oesophagus, a condition that can lead to oesophageal cancer. The innovative method offers a promising, less invasive alternative to traditional procedures like endoscopy, making cancer screening more accessible and affordable.
The capsule sponge test, which forms the basis of the BEST4 trial, takes just ten minutes to perform and can be administered by a nurse, significantly reducing both the time and costs compared to conventional endoscopic procedures. Over the next three years, the trial will recruit 120,000 people in the UK who regularly take medication for heartburn, a common symptom of Barrett’s oesophagus.
Barrett’s oesophagus is a precursor to oesophageal cancer, a potentially fatal condition where abnormal cell growth in the food pipe can lead to malignancy. Early detection and intervention are critical to reducing the risk of cancer development. The trial’s goal is to establish whether the capsule sponge test can effectively identify individuals at risk and minimise oesophageal cancer deaths.
Capsule sponge device
The capsule sponge device begins as a small, pill-sized capsule attached to a thread. After the patient swallows the capsule, it dissolves in the stomach, and a sponge inside the pill expands to the size of a 50p coin.
As the capsule is gently pulled back up the oesophagus, the sponge collects cells from the food pipe, which are then analysed for two biomarkers: Trefoil Factor 3 (TFF3), a protein specific to Barrett’s oesophagus, and altered p53 protein, which signals early signs of cancer.
The trial is a culmination of decades of research spearheaded by Professor Rebecca Fitzgerald and her team at the Early Cancer Institute, University of Cambridge, and Cancer Research UK Cambridge Centre. The technology was initially developed to address the urgent need for more accessible and effective screening methods for oesophageal cancer.
Professor Fitzgerald, also the co-principal investigator of the BEST4 trial, explained: “The capsule sponge is transforming how we detect both Barrett’s oesophagus and oesophageal cancer. Early detection means we can intervene earlier, potentially saving lives by avoiding the need for drastic treatments like chemotherapy or oesophagectomy (surgery to remove the oesophagus).”
Oesophageal cancer is one of the deadliest forms of cancer, with 9,300 new cases diagnosed each year in the UK. According to Cancer Research UK, it is the seventh most common cause of cancer-related deaths in the country, claiming around 22 lives every day. However, if caught early, oesophageal cancer is far more treatable, highlighting the importance of early-stage detection.
Potential game changer
With its simplicity, speed, and cost-effectiveness, the capsule sponge test could be a game changer for screening. Unlike endoscopy, which requires specialised equipment and is often uncomfortable for patients, the sponge test is quick and minimally invasive. It can be carried out conveniently, including mobile screening vans. These vans will be rolled out across England as part of the trial, ensuring that more people, especially those in underserved areas, can participate in the study.
The BEST4 trial has secured £6.4 million in funding from Cancer Research UK and the National Institute for Health and Care Research (NIHR). This funding will support the recruitment of participants, with invitations to join the trial being sent via text messages to people in England who are on medication for heartburn. Additionally, participants will be encouraged to join Heartburn Health, a new platform focused on clinical trials related to heartburn-linked cancers like oesophageal cancer.
For several years, the capsule sponge test has been trialled in various regions across the UK, including England, Scotland, and Northern Ireland. It has been used to help reduce the backlog in diagnostic services, especially for patients on waiting lists for endoscopy. Over 24,000 tests have already been performed in pilot studies, with early results showing that the capsule sponge test identifies Barrett’s oesophagus far more effectively than traditional GP care.
Paul Anderson, a 59-year-old stock controller from St Neots, is among the first participants in the BEST4 trial. Anderson has been managing chronic heartburn for the past decade and hopes the trial will provide new insights into his condition.
“I have been on medication for heartburn for years, and when the invitation for the trial came through, I knew I had to sign up. It is an important cause, and if this helps others get checked earlier, then I am happy to do my part,” he said.
The data collected from the trial will be crucial in determining whether the capsule sponge test can be rolled out as part of a nationwide screening programme for oesophageal cancer.
Professor Peter Sasieni, co-principal investigator of the trial and Director of the Cancer Research UK Cancer Prevention Trials Unit at Queen Mary University of London, commented: “Most people with Barrett’s oesophagus have heartburn, but most people with heartburn do not have the condition. The challenge is to prove that the test can reliably help identify those at risk of oesophageal cancer and reduce deaths.”
Hero image: The capsule sponge device begins as a small, pill-sized capsule attached to a thread. Credit: Cyted
