Development of a clinical prediction model utilising volatile organic compounds as breath biomarkers in squamous oesophageal neoplasms: ViSON, protocol for a multicentre case-control study in UK NHS hospitals
File(s)
Accepted version
Author(s)
Sharma, Sameera
Murray, James
Hanna, George
Type
Journal Article
Abstract
Introduction
Oesophageal Squamous Cell Carcinoma (OSCC) accounts for more than 85% of the global burden of Oesophageal Cancer (OC), resulting in 500,000 deaths annually. In the UK, over two-thirds of OSCC cases are diagnosed at an advanced stage, with a five-year overall survival of less than 20%. Breath-based triage tests are feasible, acceptable, and show proof-of-concept for earlier cancer detection.
Methods and analysis
The ViSON study is a multi-centre case-control study, powered to estimate breath test performance with 90% sensitivity and 80% specificity. A total of 518 participants (259 with OSCC and 259 non-cancer controls) will be recruited via a network of participating NHS trusts. Participants will provide exhaled breath samples, which will be stored on Thermal Desorption tubes, and transported to the central laboratory for processing and analysis using gas chromatography-mass spectrometry. A clinical prediction model will be developed using logistic regression with cross-validation and bootstrap methods to mitigate overfitting. Model performance will be evaluated using discrimination, calibration and accuracy. Decision curve analysis will assess clinical utility.
Ethics and dissemination
The ViSON study received ethical approval (23/PR/1300) from the Health Research Authority (HRA), and the Health and Care Research Wales (HCRW) to conduct study procedures in England and Wales. A Scotland-wide review was approved on 24/01/2024. The results of the study will be presented at national and international conferences, and a lay summary will be developed with the PPI representatives and shared using the online website, social media accounts, and charity newsletters.
Registration details
The ViSON study is registered on clinicaltrials.gov.uk - NCT06169163. All trial documents are available via the registration record.
Oesophageal Squamous Cell Carcinoma (OSCC) accounts for more than 85% of the global burden of Oesophageal Cancer (OC), resulting in 500,000 deaths annually. In the UK, over two-thirds of OSCC cases are diagnosed at an advanced stage, with a five-year overall survival of less than 20%. Breath-based triage tests are feasible, acceptable, and show proof-of-concept for earlier cancer detection.
Methods and analysis
The ViSON study is a multi-centre case-control study, powered to estimate breath test performance with 90% sensitivity and 80% specificity. A total of 518 participants (259 with OSCC and 259 non-cancer controls) will be recruited via a network of participating NHS trusts. Participants will provide exhaled breath samples, which will be stored on Thermal Desorption tubes, and transported to the central laboratory for processing and analysis using gas chromatography-mass spectrometry. A clinical prediction model will be developed using logistic regression with cross-validation and bootstrap methods to mitigate overfitting. Model performance will be evaluated using discrimination, calibration and accuracy. Decision curve analysis will assess clinical utility.
Ethics and dissemination
The ViSON study received ethical approval (23/PR/1300) from the Health Research Authority (HRA), and the Health and Care Research Wales (HCRW) to conduct study procedures in England and Wales. A Scotland-wide review was approved on 24/01/2024. The results of the study will be presented at national and international conferences, and a lay summary will be developed with the PPI representatives and shared using the online website, social media accounts, and charity newsletters.
Registration details
The ViSON study is registered on clinicaltrials.gov.uk - NCT06169163. All trial documents are available via the registration record.
Date Acceptance
2026-07-24
Citation
BMJ Open
ISSN
2044-6055
Publisher
BMJ Publishing Group
Journal / Book Title
BMJ Open
Copyright Statement
Copyright This paper is embargoed until publication. Once published the Version of Record (VoR) will be available on immediate open access.
License URL
Publication Status
Accepted