A groundbreaking clinical trial on a novel ‘pill-on-a-thread’ test has enrolled its first volunteer, aiming to evaluate its potential as a new screening method for esophageal cancer.
The BEST4 Screening investigation seeks to determine if this capsule sponge test could be effectively used to screen individuals with heartburn symptoms for Barrett’s esophagus, a precursor to esophageal cancer.
Jointly funded by the National Institute for Health Research (NIHR) and Cancer Research UK, the study is spearheaded by Cambridge University Hospitals NHS Foundation Trust (CUH) and the University of Cambridge.
Offering a quick, nurse-administered, 10-minute test, this method provides an efficient and cost-effective alternative to endoscopy. The trial intends to ascertain the test’s ability to diminish cancer treatment requirements and mortality rates associated with the disease. By leveraging UK scientific expertise and innovation, this study represents the conclusive step in a series of clinical trials designed to explore the integration of this testing method within the UK’s cancer screening framework.
Over three years, the study aims to recruit 120,000 people who use heartburn medication, as heartburn is the primary symptom of Barrett’s esophagus. The condition is marked by abnormal cell growth in the esophagus and can potentially lead to cancer.
Enrollment invitations are being distributed via text messages by NHSResearch to maximize participation across England. Participants will engage via Heartburn Health, a platform designed to facilitate involvement in clinical trials related to heartburn-associated cancers. Mobile vans will be deployed across England to administer tests during the trial.
In the UK, roughly 9,300 new esophageal cancer cases are diagnosed annually, making it the seventh leading cause of cancer-related deaths, with around 22 fatalities daily.
Paul Anderson, 59, a stock controller from St Neots, Cambridgeshire, is one of the initial participants. Reflecting on his motivation, he shared: “Though I’ve never participated in a clinical trial before, the invitation resonated with me as my acid reflux had become problematic again. Participating offers insight into my chronic heartburn and could aid others facing similar health concerns.
“I am optimistic that by contributing to this worthy initiative, I can help others receive early evaluation.”
The capsule sponge begins as a small coated pill connected to a string. Once swallowed and arrived in the stomach, the coating dissolves and the internal sponge expands to the size of a 50p coin. As gently withdrawn by a nurse or GP, this sponge captures esophageal cells, subsequently analyzed for two proteins: Trefoil Factor 3 (TFF3), indicative of Barrett’s esophagus, and the altered p53 protein, which marks cells that may become cancerous.
Funded by Cancer Research UK, previous trials confirmed the test’s safety and accuracy. The NIHR-backed BEST3 study revealed the test identifies ten times more Barrett’s esophagus cases in individuals with chronic heartburn compared to endoscopy.
To date, over 24,000 tests have been conducted in pilot programs, helping alleviate diagnostic pressures within endoscopy and NHS pathology.
Professor Rebecca Fitzgerald, Director of the Early Cancer Institute at the University of Cambridge and co-principal investigator of the trial, stated, “The capsule sponge is enhancing our detection capabilities for Barrett’s esophagus and esophageal cancer. Early identification can lower the necessity for chemotherapy and surgical procedures.
“The BEST4 Screening trial culminates years of meticulous research proving the capsule sponge’s reliability. Thousands have benefited in pilot programs, and we’re advancing towards broader testing to include everyone with heartburn.
“The BEST4 Screening trial holds the potential to significantly enhance quality of life for individuals impacted by esophageal cancer by providing crucial evidence to establish a nationally integrated screening program in the UK.”
NIHR Programmes’ Scientific Director, Professor Danny McAuley, added, “The capsule sponge presents as a revolutionary tool with promising ability to prevent esophageal cancer fatalities.
“We take great pride in initiating patient recruitment for this groundbreaking NIHR and Cancer Research UK-funded study, which we anticipate will define future routine screening endeavors against this lethal ailment.
“Numerous participants are required for this trial, and we appeal to individuals to enroll. This pivotal research will benefit patients, aiding NHS service planners and implementers in optimizing disease detection methods.”
Andrew Gwynne, Minister for Public Health and Prevention, remarked, “This trial exemplifies leveraging technological advancements to enhance patient experience and accelerate diagnosis.
“This innovation could streamline life-saving screenings, alleviating NHS resource constraints.
“As part of our 10-Year Health Plan to implement sweeping NHS reform, we are unwavering in our cancer combat strategy, striving to ensure patients can access pioneering, government-supported research initiatives.”
The Cancer Research UK Cancer Prevention Trials Unit at Queen Mary University of London is responsible for designing the trial and analyzing ensuing data outcomes. The trial solicits men over 55 and women over 65 taking chronic heartburn medications.
NIHR provides funding through its Health Technology Assessment (HTA) Programme.
Support for BEST4 is extended by NIHR’s Research Delivery Network (RDN), which facilitated the acquisition of mobile screening vehicles essential for extending the trial to community settings.
Formerly known as the Clinical Research Network, RDN also reinforced BEST3 via patient recruitment, GP practice integration, and the training of research nurses to administer the innovative pill-on-a-string diagnostic test.