Barretts oesophagus screening trial in a case control study

ISRCTN	ISRCTN12730505
DOI	https://doi.org/10.1186/ISRCTN12730505
Protocol serial number	A091986, Ethics reference - 10/H0308/71
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funder	Cancer Research UK (CRUK) (UK)

Submission date: 16/06/2011
Registration date: 05/08/2011
Last edited: 18/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-to-see-how-well-a-new-way-screening-for-barretts-oesophagus-works-best2

Contact information

Dr Rebecca Fitzgerald
Scientific

Box 197 Hutchison / MRC Research Centre
Hills Road
Cambridge
CB2 0XZ
United Kingdom

Phone	+44 (0)122 376 3287
Email	rcf29@hutchison-mrc.cam.ac.uk

Study information

Primary study design	Observational
Study design	Case control study
Secondary study design	Case-control study
Study type	Participant information sheet
Scientific title	Evaluation of a non-endoscopic immunocytological device (Cytosponge) for Barretts oEsophagus Screening Trial in a case control study: BEST 2
Study acronym	BEST 2
Study objectives	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(s)	National Research Ethics Services Cambridgeshire Research Ethics Committee, 25/10/2010, ref: 10/H0308/71
Health condition(s) or problem(s) studied	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 Barretts 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 Barretts oesophagus (BE) and controls individuals with reflux or indigestion (dyspepsia) symptoms referred for endoscopy. Four centres with expertise in Barretts 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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1400
Key inclusion criteria	1. Any participant 18 years and above clinically fit for an endoscopy with Barretts 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
Key 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
Date of first enrolment	07/07/2011
Date of final enrolment	31/12/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Hutchison/MRC Research Centre

Cambridge
CB2 0XZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/04/2017: Publication reference added.
08/02/2016: The overall trial end date was changed from 01/01/2014 to 31/12/2016.

Barretts oesophagus screening trial in a case control study