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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30075763