Development of a clinical prediction model using volatile organic compounds as breath biomarkers in squamous oesophageal neoplasms: ViSON, protocol for a multicentre case-control study in UK NHS hospitals.
Oesophageal squamous cell carcinoma (OSCC) accounts for more than 85% of the global burden of oesophageal cancer, resulting in 500 000 deaths annually. In the UK, over two-thirds of OSCC cases are diagnosed at an advanced stage, with a 5-year overall survival of less than 20%. Breath-based triage tests are feasible, acceptable and show proof of concept for earlier cancer detection.
The Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms (ViSON) study is a multicentre 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 National Health Service 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.
The ViSON study received ethical approval from the London - Riverside Research Ethics Committee (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 January 2024. The results of the study will be presented at national and international conferences, and a lay summary will be developed with the patient and public involvement representatives and shared using the online website, social media accounts and charity newsletters.
NCT06169163.
The Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms (ViSON) study is a multicentre 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 National Health Service 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.
The ViSON study received ethical approval from the London - Riverside Research Ethics Committee (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 January 2024. The results of the study will be presented at national and international conferences, and a lay summary will be developed with the patient and public involvement representatives and shared using the online website, social media accounts and charity newsletters.
NCT06169163.
Authors
Sharma Sharma, Murray Murray, Parker Parker, Jamel Jamel, Antonowicz Antonowicz, Phillips Phillips, Bailey Bailey, Fox Fox, Plant Plant, Converso Converso, Ellis Ellis, Mukherjee Mukherjee, Kumar Kumar, Lo Lo, Wahed Wahed, Alchawaf Alchawaf, Moore Moore, Boddy Boddy, Scott-Brown Scott-Brown, Thomas Thomas, Abdelrahman Abdelrahman, Pucher Pucher, El-Sharkawy El-Sharkawy, Forner Forner, Wayman Wayman, Elshaer Elshaer, Chan Chan, Mcnally Mcnally, Petty Petty, Patil Patil, Bhuva Bhuva, Periyathambi Periyathambi, Bhatt Bhatt, Vohra Vohra, Sharples Sharples, Hanna Hanna,
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