An Expanded inVestigation of Inflammacheck™ to Measure Exhaled Breath CondensaTe Hydrogen perOxide in RespiratorY Conditions A Cross-sectional, Observational Study Comparing Exhaled Breath Biomarkers Across Respiratory Diseases and Healthy Volunteers.
Lung cancer remains the leading cause of cancer-related death in the UK, with over 35,000 deaths annually and most cases diagnosed at a late stage. Current screening programmes using low-dose CT scans target only high-risk individuals, missing around 30% of lung cancer cases, including many women and never-smokers. There is no simple, non-invasive tool to help triage patients with persistent respiratory symptoms who fall outside formal screening criteria. Inflammacheck® measures hydrogen peroxide and other breath biomarkers linked to airway inflammation and oxidative stress. Preliminary studies (VICTORY and ExPeL) have shown strong diagnostic performance for distinguishing lung cancer from other respiratory conditions. VICTORY 2 aims to validate and refine the AI model supporting Inflammacheck®, enabling accurate, rapid, and affordable triage for suspected lung cancer in NHS settings.
⁃ \- 1. Age: Adults aged ≥18 years. 2. Consent: Willing and able to provide written informed consent (prospective participants only).
⁃ 3\. Clinical status: Belong to one of the defined diagnostic categories listed below:
• Group A: Lung cancer confirmed by multidisciplinary team (MDT) diagnosis.
• Group B: Suspected lung cancer (biopsy negative or awaiting further investigation).
• Group C: Pneumonia (radiologically or clinically confirmed).
• Group D: Non-malignant airways diseases (asthma or COPD).
• Group E: Other non-malignant respiratory diseases (interstitial lung disease, bronchiectasis, breathing pattern disorder).
• Group F: Healthy controls with no known respiratory disease. 4. Clinical documentation: Availability of relevant diagnostic and demographic data to confirm disease classification (for retrospective participants).
• 5\. Previous participation: Individuals previously enrolled in the VICTORY or ExPeL studies may be included for retrospective data integration.
• 6\. Willing and able to perform a breath test using the Inflammacheck® device. 7. Willing to allow access to relevant clinical data and imaging results 8. Be able to understand and communicate in English with or without the need for a translator, to ensure informed consent and comprehension of study procedures