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.
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Sharma Sameera, Murray James, Parker Aaron, Jamel Sara, Antonowicz Stefan, Phillips Adele, Bailey Elaine, Fox Lyn, Plant Christine, Converso Valerio, Ellis James K, Mukherjee Somnath, Kumar Bhaskar, Lo Terence, Wahed Shajahan, Alchawaf Alia, Moore Andrew R, Boddy Alex, Scott-Brown Martin, Thomas Betsan, Abdelrahman Tarig, Pucher Philip H, El-Sharkawy Ahmed, Forner Samantha, Wayman John, Elshaer Ahmed, Chan David, Mcnally Stephen, Petty Russell, Patil Pradeep, Bhuva Neel, Periyathambi Jambulingam, Bhatt Lubna, Vohra Ravinder, Sharples Linda, Hanna George B, ViSON Collaborators
Аннотация
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: NCT06169163.