Full title of Study: Evaluation of a Non-Endoscopic Immunocytological Device (Cytosponge) for Barrett’s Esophagus Screening in a Case-Control Study (BEST2).
Study Objectives: 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).
Study Design: Multicentre, Case-control Study.
Cases: patients with known BE.
Controls: individuals with reflux or indigestion (dyspepsia) symptoms referred for endoscopy.
Participating Centres: MRC Cancer Unit and Addenbrooke's Hospital Cambridge, Queens Medical Centre Nottingham University Hospital, UCL Cancer Institute and University College London Hospitals, Newcastle Freeman Hospital.
Number of Participants: 500-700 cases and 500-700 controls.
- Safety and performance characteristics of the Cytosponge test for diagnosing BE compared with endoscopy, including specificity (from controls) and sensitivity (from cases).
- Differential sensitivity of screening BE with dysplasia (low and high grade) compared to non-dysplastic BE.
- 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.
- For patients with BE, the ability of Cytosponge biomarkers to risk stratify patients in comparison with dysplasia grade obtained from endoscopic biopsies.
- 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.
Status of the study: Recruiting.
Portfolio: The study has been adopted into the UKCRN portfolio (ID 9461).
- R Fitzgerald (Chief Investigator, Cambridge)
- K Ragunath (Principal Investigator, Nottingham)
- M Griffin (Principal Investigator, Newcastle)
- L Lovat (Principal Investigator, London)
- I Debiram-Beecham (Trial Coordinator, Cambridge)
- P Lao-Sirieix (Group Research Manager, Cambridge)
- C Ross-Innes (Post-Doctoral Fellow, Cambridge)
- E Walker (Research Assistant, Cambridge)
- M O’Donovan (Consultant Pathologist, Cambridge)
- C Wilson (Research Nurse, Cambridge)
- E Dewhurst (Trial Administrator, Cambridge)
- P Sasieni (Trial Statistician, Cambridge)
CLRN via UKCRN portfolio
Contacts: Irene Debiram
Range of pathologies diagnosed using a minimally invasive capsule sponge to evaluate patients with reflux symptoms. Paterson AL, Lao-Sirieix P, O'Donovan M, Debiram-Beecham I, di Pietro M, Miremadi A, Attwood SE, Walter FM, Sasieni PD, Fitzgerald RC; BEST BEST2 study groups. Histopathology. 2016 Jul 15. [Epub ahead of print]
Evaluation of a minimally invasive cell sampling device coupled with assessment of trefoil factor 3 expression for diagnosing Barrett's esophagus: a multi-center case-control study. Ross-Innes CS, Debiram-Beecham I, O'Donovan M, Walker E, Varghese S, Lao-Sirieix P, Lovat L, Griffin M, Ragunath K, Haidry R, Sami SS, Kaye P, Novelli M, Disep B, Ostler R, Aigret B, North BV, Bhandari P, Haycock A, Morris D, Attwood S, Dhar A, Rees C, Rutter MD, Sasieni PD, Fitzgerald RC; BEST2 Study Group. PLoS Med. 2015 Jan 29;12(1):e1001780. eCollection 2015 Jan.