Barrett's oEsophagus (BE) is the main risk factor for cancer of the oesophagus. It is most likely to be diagnosed in people who have a long history of burning indigestion - a sign of acid reflux.

People who are known to have BE are usually seen regularly by a doctor and have regular endoscopies. The aim of the regular endoscopies is to diagnose the cancer at an early treatable stage.

Associations of gastroenterologists worldwide have not recommended screening for BE using endoscopy because of its prohibitive cost. Furthermore, its use would completely overburden endoscopy units nationwide.

The Barrett's oEsophagus Screening Trial (BEST2) is looking at whether a new device called the Cytosponge coupled with a molecular test would offer a suitable alternative to diagnose BE in the general population.

Participants will be asked to swallow the Cytosponge with a small glass of water. The 'capsule' contains a small sponge attached to a piece of string. The gelatine of the capsule dissolves in the stomach and after 5 minutes the 'sponge' is removed by pulling gently on the string. The Cytosponge collects a sample of the cells lining your gullet (oesophagus).

Additional details about the trial

BEST2 is evaluating a non-endoscopic immunocytological device (Cytosponge) for Barrett's Esophagus (BE) screening in a case-control study:

Cases

patients with known BE

Controls

individuals with reflux or indigestion (dyspepsia) symptoms referred for endoscopy

The purpose of the trial is to obtain more accurate data on the potential of the Cytosponge as a screening modality and to find out its potential to determine the risk of cancer progression (in conjunction with biomarkers of risk).

All participants will swallow the Cytosponge device prior to having a clinically indicated endoscopy and the Cytosponge will be processed for a number of different biomarkers. The results will be compared with the endoscopy findings.

Number of Participants

500-700 cases and 500-700 controls

Study Duration

3 years

Number of sites

4 UK centres with expertise in BE

Objectives (summary)

1. Safety and performance characteristics of the Cytosponge test for diagnosing BE compared with endoscopy, including specificity (from controls) and sensitivity (from cases)
2. Differential sensitivity of screening BE with dysplasia (low and high grade) compared to non-dysplastic BE.
3. Determine the reproducibility of the Cytosponge result by repeat testing in a subset of controls and Barrett's patients attending for clinically indicated repeat surveillance during the trial period.
4. For patients with BE, the ability of Cytosponge biomarkers to risk stratify patients in comparison with dysplasia grade obtained from endoscopic biopsies.
5. Logistics of high-throughput sample processing and automated analysis of Cytosponge specimens for use in routine NHS or other health care settings.

Main inclusion criteria

Any patient clinically fit for an endoscopy with Barrett's oesophagus (for the cases) and (or) with upper GI symptoms of reflux or dyspepsia as an indication for endoscopy.