Wolfson Institute of Preventive Medicine - Barts and The London

Barrett's oEsophagus STudy 2 (BEST2)

Centre for Cancer Prevention

Project Investigator:  Professor Peter Sasieni

Overview

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

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 ul>
  • 4 UK centres with expertise in BE

Objectives

  • 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.

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.

Patient Confidentiality

BEST2 Trial:  How we handle person-identifiable data (Important information for BEST2 participants)

We handle BEST2 participants' data in line with the Data Protection Act (1998). The patient information sheet given to all participants, states that they may withdraw from the study at any time without reason and no further data or research will be collected once that participant has withdrawn.  Participants can contact University of Cambridge Hospitals NHS Foundation Trust Patient Advice and Liaison Service (PALS) on 01223 216 756 should they wish to withdraw from participation at any time.  They can also contact the Research Nurse, Tara Nuckcheddy- Grant on 01223 763994 or tara.nuckcheddy-grant@nhs.net

All BEST2 participants are encouraged to maintain contact with their trial nurse and inform them of any change to contact details as well as any significant health events.  Based on patient consent, NHS registries are being used to supplement and confirm events reported by the BEST2 trial.  Existing registries will be providing data on cancer incidence and mortality.  Further data will also be collected via the Hospital Episode Statistics (HES) which utilises in-patient, out-patient and A&E data.

The process for receiving healthcare data will involve University of Cambridge sending a list of the cohorts NHS linkage information which will include NHS Number, surname, forename, date of birth, post code, sex and a unique identifier.  Once matched with HES and cancer registry records held by the NHS Health and Social Care Information Centre (HSCIC) they will send the data set back to the trial site at University of Cambridge who will update the cohort data.  All identifiable variables will be removed from the data set before a de-identified version is sent to the trial's partner site and data controller at Queen Mary’s University of London Cancer Prevention Trials Unit for further processing on baseline and cancer variables.  The data from any participants who have withdrawn from participation of the study will not be sent to the HSCIC (http://www.hscic.gov.uk/) for any data linkages.