Condition category
Digestive System
Date applied
16/06/2011
Date assigned
05/08/2011
Last edited
08/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Rebecca Fitzgerald

ORCID ID

Contact details

Box 197 Hutchison / MRC Research Centre
Hills Road
Cambridge
CB2 0XZ
United Kingdom
+44 (0)122 376 3287
rcf29@hutchison-mrc.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A091986, Ethics reference - 10/H0308/71

Study information

Scientific title

Evaluation of a non-endoscopic immunocytological device (Cytosponge) for Barrett’s oEsophagus Screening Trial in a case control study : BEST 2

Acronym

BEST 2

Study hypothesis

The purpose of the study is to obtain more accurate data on the potential of the Cytosponge as a screening modality (in conjunction with trifoil factor (TFF3) for Barrett's oesophagus (BE), and to find out its potential to determine the risk of cancer progression (in conjunction with biomarkers of risk).

The primary objectives of the study are:
1. Performance and safety characteristics of the Cytosponge test
2. Effectiveness of the Cytosponge for diagnosing BE compared with endoscopy, including specificity (from controls) and sensitivity (from cases).
3. For patients with BE, the ability of Cytosponge biomarkers to risk stratify patients, according to their future cancer risk, in comparison with the dysplasia grade obtained from endoscopic biopsies.

Ethics approval

National Research Ethics Services Cambridgeshire Research Ethics Committee, 25/10/2010, ref: 10/H0308/71

Study design

Case control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Barrett's oesophagus

Intervention

500-700 cases and 500-700 controls [a range is given because this will vary slightly depending on the prevalence of dysplastic cases in order to give us 100 cases of low grade dysplasia (LGD) and 100 high grade dysplasia (HGD)]. 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. Individuals must be able to provide informed consent.

A case control study design in which the cases will be patients with known Barrett’s oesophagus (BE) and controls individuals with reflux or indigestion (dyspepsia) symptoms referred for endoscopy. Four centres with expertise in Barrett’s oesophagus will recruit patients. All participants will swallow the Cytosponge device prior to having an endoscopy. The Cytosponge will be processed for a number of different biomarkers. The results will be compared with the endoscopy findings.

Statistical methods for proportions including estimation of proportions with confidence intervals and testing for difference between two proportions and trends in proportions.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Performance and safety characteristics of the Cytosponge test
2. Effectiveness of the Cytosponge for diagnosing BE compared with endoscopy, including specificity (from controls) and sensitivity (from cases)
2. For patients with BE, the ability of Cytosponge biomarkers to risk stratify patients in comparison with dysplasia grade obtained from endoscopic biopsies

Secondary outcome measures

1. Differential sensitivity of screening BE with dysplasia (low and high grade) compared to non-dysplastic BE
2. Determine the reproducibility of the Cytosponge result by repeated testing in a subset of individuals
3. Logistics of high-throughput sample processing and automated analysis of Cytosponge specimens for use in routine National Health Services (NHS) or other health care settings.

Overall trial start date

07/07/2011

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Any participant 18 years and above clinically fit for an endoscopy with Barrett’s oesophagus (Cases) with or without upper gastrintestinal (GI) symptoms
2. Any participant 18 years and above clinically fit for an endoscopy with upper GI symptoms of reflux or dyspepsia as an indication for endoscopy / gastroscopy (Controls)
3. Ability to provide informed consent
4. Patients who have undergone endoscopic mucosal resection (EMR) for high grade dysplasia and due for repeat endoscopy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000-1400

Participant exclusion criteria

1. Individuals with a diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour, or symptoms of dysphagia
2. Oesophageal varices, stricture or requiring dilatation of the oesophagus
3. On anticoagulation therapy / medication (warfarin, clopridogrel, heparin or tinzaparin)
4. Individuals who have had a myocardial infarction or any cardiac event less than six months ago
5. Individuals who have had a cerebrovascular event < 6 months ago where their swallowing has been affected
6. Patients who have had previous treatment such as photodynamic therapy (PDT) or radio frequency ablation (RFA)
7. Participants who are unable to provide informed consent
8. Participants under age 18
9. Participants who exclude beef from their diet as the gelatine is beef based. This can be discussed with the patient
10. Endoscopy is generally avoided in pregnant women and therefore it is unlikely that any pregnant women will be included although pregnancy would not be an absolute contraindication. Pregnancy / pregnancy test will not be recorded as part of the trial

Recruitment start date

07/07/2011

Recruitment end date

31/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hutchison/MRC Research Centre
Cambridge
CB2 0XZ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 08/02/2016 the overall trial end date was changed from 01/01/2014 to 31/12/2016.