Heartburn Health and BEST4 Study
Thomas is working as Principal Investigator (PI) on the Heartburn Health Programme and BEST4 trial with colleagues at QMUL (Professor Peter Sasieni) and Cambridge (Professor Rebecca Fitzgerald).
This study has joint funding between NIHR HTA and CRUK (total funding is over £6m). The overall aim of this project is to determine whether a test called the capsule sponge can be used to reduce the number of deaths due to oesophageal cancer (OAC) in males aged 55-79 years and females aged 65-79 years with any longstanding heartburn or acid reflux medications. OAC is has a poor prognosis, and the current clinical pathways are ineffective for early diagnosis. Since endoscopic therapy for dysplasia and early cancer occurring in the premalignant condition Barrett’s oesophagus (BO) is now very effective, there is now a clear need for improving methods to identify those patients at high risk of requiring treatment.
The capsule sponge test is an easier, more convenient, and affordable alternative to endoscopy that can be done in a clinic or mobile unit by trained staff. The procedure itself takes less than 10 minutes and involves swallowing a capsule that contains a sponge tied to a long string. The patient swallows the capsule, waits for the capsule to dissolve in their stomach so the sponge can expand, then a nurse pulls on the string to bring the sponge back up the oesophagus and out of their mouth. As the sponge comes up, it collects cells that can then be tested to see if they have abnormalities that suggest the person has BO. In some cases, it even detects cells that suggest early-stage cancer, which enables a person to receive curative treatment. Without this test those cancers might not have been detected until they were more advanced and causing more obvious symptoms.
Previous studies have shown that patients generally find it an acceptable procedure. Some people find it a bit uncomfortable when the sponge is pulled out, but they still consider it tolerable, and some people much prefer the sponge procedure to an endoscopy. Overall, these previous studies have demonstrated that the capsule sponge test is an effective and easy way of detecting BO. However, what the previous studies have not specifically looked at is how effective the test is at saving people’s lives. We know that it successfully detects BO, but to be able to understand how many lives it can potentially save, we need to run a large study over a longer period.
That is what this BEST4 project proposes to do. It is comprised of two related studies: (1) a targeted screening study to determine the extent to which the capsule sponge test can prevent people from dying from OAC, and (2) a surveillance study looking at whether the capsule sponge test can be used to tell whether a person is at low or high risk of developing cancerous cells in the oesophagus.
The recruitment will be a novel approach primarily using text messaging to recruit males aged 55-79 years and females aged 65-79 years with any longstanding heartburn or acid reflux medications. We aim to recruit over 120,000 people to the heartburn health programme, where they will consent to being contacted to take part in research studies and for health data sharing. This includes for the BEST4 study and potentially other studies too. Upon consenting to join the heartburn health programme, participants will be asked if they would be interested in a capsule sponge test if it was available locally. Those that express interest will be randomised to either control or intervention arm respectively. Those in the control arm will not be contacted again nor consented to the Screening trial (Zelen design). Those in the investigational arm (aim for n=40,000) will then be invited to book an appointment on a local mobile unit in order to have the capsule sponge test.
If successful the BEST4 studies could lead to validation of a capsule sponge test-based screening and surveillance strategy for BO and OAC that, if successful, would be a step-change for the field. Additionally, they will create a platform for basic, clinical, and epidemiological research into BO and OAC. This will include a longitudinal tissue bank of capsule sponge, saliva and blood samples in patients undergoing endoscopy. With the heartburn health programme, we will have a large population cohort with consent for longitudinal data collection and the opportunity for further research studies and data linkage, including trials for patients with acid reflux and chemoprevention among patients with BO.
Can a capsule sponge change how we diagnose oesophageal cancer? – Cancer Research UK – Cancer News