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Not Yet RecruitingNCT07426718

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

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.

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
140 (estimated)
Sponsor
Portsmouth Hospitals NHS Trust · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNo interventionThis 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.

Timeline

Start date
2026-03-02
Primary completion
2026-09-30
Completion
2026-12-30
First posted
2026-02-23
Last updated
2026-02-23

Source: ClinicalTrials.gov record NCT07426718. Inclusion in this directory is not an endorsement.