BEST3 - A trial of a new GP-based test for patients with heartburn symptoms
ISRCTN | ISRCTN68382401 |
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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
Plain English summary of protocol
Contact information
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 |
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amr75@MRC-CU.cam.ac.uk |
Study information
Study design | Randomized; Interventional; Design type: Diagnosis, Device, Management of Care |
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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 |
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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
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
Box 197
Addenbrookes Hospital
Cambridge Biomedical Campus
Cambridge
CB2 0XZ
United Kingdom
Sponsor information
Hospital/treatment centre
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
Phone | +44 (0)1223 348490 |
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Research@addenbrookes.nhs.uk | |
https://ror.org/04v54gj93 |
Funders
Funder type
Charity
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 |
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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? |
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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.