Study to Validate Inflammacheck Breath Test for Detecting Lung Cancer and Other Respiratory Diseases Using AI to Analyze Breath Biomarkers in Adults with Lung Conditions or Healthy Volunteers

What this Trial Is About

Lung cancer is the leading cause of cancer deaths in the UK, often diagnosed late. Current screening mainly targets high-risk groups, missing about 30% of cases, including many women and never-smokers. There is a need for a simple, non-invasive test to help triage patients with persistent respiratory symptoms who do not meet current screening criteria. The Inflammacheck4 device measures hydrogen peroxide and other breath markers linked to airway inflammation and oxidative stress. Previous studies showed it could distinguish lung cancer from other respiratory diseases well. This study aims to validate and improve the AI model behind Inflammacheck4 for quick and accurate lung cancer triage in NHS settings. This is a multi-center, observational study without intervention or randomization. Participants include healthy volunteers and people with lung cancer, suspected lung cancer negative biopsy, pneumonia, non-malignant airway diseases, or other respiratory conditions. The study collects exhaled breath samples using Inflammacheck4 alongside demographic and clinical data. The AI model will be refined by analyzing these breath biomarkers across the different groups. The study includes both retrospective and prospective data integration. Participants will provide breath samples and allow access to clinical data and imaging results. The primary outcome is to refine the AI-based diagnostic model from enrollment until study completion in December 2026. Participants must be able to understand English and perform the breath test. The study excludes those with active infections other than pneumonia, recent major lung surgery, recent cancer treatments, pregnancy, or recent smoking or certain medication use. The total participation time depends on individual enrollment and data collection timing.

A Study Measuring Markers of Airway Inflammation in Breath Samples From People With Respiratory Diseases and Healthy Volunteers.