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NOT YET RECRUITING
NCT07426718

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

Sponsor: Portsmouth Hospitals NHS Trust

View on ClinicalTrials.gov

Summary

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

140

Start Date

2026-03-02

Completion Date

2026-12-30

Last Updated

2026-02-23

Healthy Volunteers

Yes

Interventions

OTHER

No intervention

This is a multi-centre, mixed retrospective-prospective observational study with no intervention or randomisation. The study involves data analysis and AI model development based on exhaled breath measurements, demographic data, and clinical diagnosis.