A pivotal clinical trial is underway to determine if a novel 'pill-on-a-thread' innovation can become a new screening program for oesophageal cancer. Cambridge Cancer Research Hospital announced the commencement of the BEST4 Screening trial, which will assess the efficacy of Medtronic's Cytosponge-TFF3 in detecting Barrett's oesophagus, a condition that can lead to oesophageal cancer.
The BEST4 Screening trial (ISRCTN85044808) will recruit 120,000 patients over the next three years who are currently taking medication for heartburn, the most common symptom of Barrett’s oesophagus. Eligible participants, including men over 55 and women over 65, will be invited via text message from NHS Research to join Heartburn Health, a new platform designed to support clinical trial participation in heartburn-linked cancers. Mobile screening vans will be stationed across England to facilitate convenient testing.
The capsule sponge test, which takes approximately ten minutes, is administered by a nurse and involves the patient swallowing a small, gelatine capsule attached to a string. The capsule dissolves in the stomach, releasing a sponge that expands to the size of a 50p coin. As the sponge is gently pulled out, it collects oesophageal cells, which are then tested for Trefoil Factor 3 (TFF3), a marker for Barrett’s oesophagus, and altered p53 protein, which indicates potential oesophageal cancer.
Potential to Transform Oesophageal Cancer Screening
Professor Rebecca Fitzgerald, director of the Early Cancer Institute at the University of Cambridge and honorary consultant in cancer medicine at Addenbrooke’s Hospital, designed the 'pill-on-a-thread.' She stated, "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."
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."
Backing and Collaboration
The BEST4 Screening trial is a collaborative effort led by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge. The trial design and results analysis are being managed by the Cancer Research UK Cancer Prevention Trials Unit at Queen Mary University of London (QMUL). The trial is supported by £6.4 million in funding from Cancer Research UK and the National Institute for Health and Care Research (NIHR).
Impact and Context
In the UK, approximately 9,300 new cases of oesophageal cancer are diagnosed annually, making it the seventh most common cause of cancer death, with around 22 deaths per day. The BEST4 Screening trial builds upon the success of the BEST3 study (ISRCTN68382401), which demonstrated that the capsule sponge detected ten times as many cases of Barrett’s oesophagus in people with chronic heartburn compared to routine GP care. To date, over 24,000 capsule sponge tests have been performed in pilot programs, contributing to the reduction of diagnostic backlogs in endoscopy and NHS pathology.
