BEST3 - A trial of a new GP-based test for patients with heartburn symptoms

ISRCTN	ISRCTN68382401
DOI	https://doi.org/10.1186/ISRCTN68382401
Secondary identifying numbers	CPMS 32540

Submission date: 16/01/2017
Registration date: 19/01/2017
Last edited: 14/02/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-the-cytosponge-test-in-gp-surgeries-for-people-with-heartburn-symptoms-best-3#undefined

Study website

Contact information

Ms Aisling Redmond
Public

Cancer Research UK & King's College London Cancer Prevention Trials Unit
Cancer Prevention Trials Unit (CPTU), Cancer Prevention Group
School of Cancer & Pharmaceutical Sciences
King’s College London
GH0603004 Research Oncology Seminar Room
Floor 3, Bermondsey Wing
Guy’s Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Phone	+44 (0)207 882 2932
Email	amr75@MRC-CU.cam.ac.uk

Study information

Study design	Randomized; Interventional; Design type: Diagnosis, Device, Management of Care
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Diagnostic
Study type	Participant information sheet
Scientific title	Barrett’s oESophagus Trial 3 (BEST3): randomised controlled trial comparing the Cytosponge™-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care.
Study acronym	BEST3
Study objectives	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(s)	East of England – Cambridge East REC, 21/12/2016, ref: 16/EE/0546
Health condition(s) or problem(s) studied	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
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 study start date	01/05/2016
Completion date	01/09/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	50 Years
Sex	Both
Target number of participants	Planned Sample Size: 9000; UK Sample Size: 9000
Total final enrolment	13514
Key inclusion criteria	1. Aged 50 years and over 2. Records of at least 6 months of prescription for acid-suppressant medication in the last year
Key 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
Date of first enrolment	15/03/2017
Date of final enrolment	01/05/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Cancer Research UK & King's College London Cancer Prevention Trials Unit

Cancer Prevention Trials Unit (CPTU), Cancer Prevention Group
School of Cancer & Pharmaceutical Sciences
King’s College London
GH0603004 Research Oncology Seminar Room
Floor 3, Bermondsey Wing
Guy’s Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

MRC Cancer Unit

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

Sponsor information

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Hospital/treatment centre

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone	+44 (0)1223 348490
Email	Research@addenbrookes.nhs.uk
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date	31/03/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	Detailed datasets generated during the study for publication purposes will be available in the form of data supplements to the main journal publication and will be accessible as summary tables and analyses immediately upon publication. This may also include de-identified line-level participant data of a limited number of data fields to protect privacy. The full trial dataset is not expected to be made available due to data protection responsibilities and proprietorial issues around data use.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	03/08/2018		Yes	No
Results article	results	01/08/2020	04/08/2020	Yes	No
Results article	secondary results: patient experience	10/01/2023	11/01/2023	Yes	No
HRA research summary			26/07/2023	No	No
Other publications	Patient-reported experiences and views	07/04/2022	14/02/2024	Yes	No
Participant information sheet		03/08/2018	14/02/2024	No	Yes

Editorial Notes

14/02/2024: Publication reference and participant information sheet added.
11/01/2023: Publication reference added.
04/08/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
18/05/2020: Contact details updated.
14/01/2020: IPD sharing statement added.
07/01/2020: The following changes were made to the trial record:
1. The scientific title was changed from '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.' to 'Barrett’s oESophagus Trial 3 (BEST3): randomised controlled trial comparing the Cytosponge™-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care.'
2. The trial participating centres were updated to remove Barts Clinical Trials Unit and add 'Cancer Research UK & King's College London Cancer Prevention Trials Unit'.
3. The intention to publish date was changed from 31/12/2019 to 31/03/2020.
4. Contact details updated.
06/08/2018: Publication reference added.
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.