Condition category
Cancer
Date applied
16/01/2017
Date assigned
19/01/2017
Last edited
15/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Ms Beth Muldrew

ORCID ID

Contact details

Centre for Cancer Prevention
Queen Mary University of London
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
+44 (0)207 882 2932
b.muldrew@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32540

Study information

Scientific title

Barrett’s oESophagus Trial 3 (BEST3): cluster randomised controlled trial comparing the Cytosponge™-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care.

Acronym

BEST3

Study hypothesis

The aim of this study is to:
1. Demonstrate that the invitation to the Cytosponge-TFF3 test leads to an increase in the number of patients diagnosed with Barrett’s oesophagus (BE) compared to the usual clinical care pathway in primary care
2. Gain an in-depth understanding of the health economics of the Cytosponge -TFF3 test in patients on long-term treatment with acid suppressants as well as the economics for the projected reduction of cancer-related deaths

Ethics approval

East of England – Cambridge East REC, 21/12/2016, ref: 16/EE/0546

Study design

Randomised; Interventional; Design type: Diagnosis, Device, Management of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

Specialty: Primary Care, Primary sub-specialty: Cancer; UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of oesophagus, stomach and duodenum, Cancer/ Malignant neoplasms of lip, oral cavity and pharynx

Intervention

120 practices will be randomised on a 1:1 basis to either the intervention or control arm. Practices will be randomised via block randomisation and be stratified by number of eligible patients. A cluster randomisation will be used to simplify research procedures and minimise impact of differing clinical practice within the same practice.

Intervention arm: Participants on long-term acid suppressant medication will receive the Cytosponge™ -TFF3 test and a clinically-indicated endoscopy where required and followed up at 12 months.

Control arm: Participants will receive usual care and followed up at 12 months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Effectiveness is assessed using GP and hospital records of histologically-confirmed Barrett’s oesophagus at 12 months post GP recruitment.

Secondary outcome measures

1. Cost-effectiveness is assessed using GP and hospital records to determine mean cost per patient receiving the Cytosponge™ -TFF3 test versus usual care and incremental cost per QALY gained of the Cytosponge™ TFF3 test versus usual care at 12 months post GP recruitment
2. Patient acceptability is measured using a bespoke questionnaire at 7-14 days post procedure
3. Accuracy is measured using Positive Predictive Value (PPV) and Negative Predictive Value (NPV) in relation to the length of BE at 12 months post GP recruitment
4. Safety is measured using number of adverse events reported by patients up to 7 days post procedure

Overall trial start date

01/05/2016

Overall trial end date

01/09/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 50 years and over
2. Records of at least six months of prescription for acid-suppressant medication in the last year

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 9000; UK Sample Size: 9000

Participant exclusion criteria

Current exclusion criteria as of 15/08/2017:
1. Recorded regular prescriptions of NSAIDs
2. Recorded upper GI endoscopy in the previous 5 years as identified from the practice database
3. Recorded diagnosis of a current or previous oro-pharynx, oesophageal or gastro-oesophageal tumour
4. Recorded diagnosis of Barrett’s oEsophagus (BE)
5. Unable to attend the GP surgery
6. Deemed not fit enough by their GP

Previous exclusion criteria:
1. Recorded regular prescriptions of NSAIDs
2. Recorded regular prescription of Clopidogrel
3. Recorded upper GI endoscopy in the previous 5 years as identified from the practice database
4. Recorded diagnosis of a current or previous oro-pharynx, oesophageal or gastro-oesophageal tumour
5. Recorded diagnosis of Barrett’s oEsophagus (BE)
6. Unable to attend the GP surgery
7. Deemed not fit enough by their GP

Recruitment start date

15/03/2017

Recruitment end date

01/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts Clinical Trials Unit
Centre for Cancer Prevention Queen Mary University of London Wolfson Institute of Preventive Medicine Charterhouse Square
London
EC1M 6BQ
United Kingdom

Trial participating centre

MRC Cancer Unit
University of Cambridge Box 197 Addenbrookes Hospital Cambridge Biomedical Campus
Cambridge
CB2 0XZ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Sponsor details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 348490
Research@addenbrookes.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research 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

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/03/2017: Cancer Help UK lay summary link added to plain English summary field. 27/02/2017: The recruitment start date was changed from 01/02/2017 to 15/03/2017.