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

Not Applicable

Completed

• Conditions: 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; Cancer; Barrett’s esophagus

• Registration Number: ISRCTN68382401
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30075763 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32738955/ results (added 04/08/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36627580/ secondary results: patient experience (added 11/01/2023) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35393308/ Patient-reported experiences and views (added 14/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-19
• Study Completion: 2019-09-01
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 13514

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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<br>2. Patient acceptability is measured using a bespoke questionnaire at 7-14 days post procedure<br>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<br>4. Safety is measured using number of adverse events reported by patients up to 7 days post procedure