Actively Recruiting
Expanded Investigation of Inflammacheck to Measure Breath Hydrogen Peroxide in Respiratory Diseases A Cross-sectional Observational Study Comparing Breath Biomarkers in Lung Cancer, Pneumonia and Healthy Volunteers
Led by Portsmouth Hospitals NHS Trust · Updated on 2026-05-08
140
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study Measuring Markers of Airway Inflammation in Breath Samples From People With Respiratory Diseases and Healthy Volunteers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Willing and able to provide written informed consent (for prospective participants)
- Diagnosed with lung cancer confirmed by multidisciplinary team
- Suspected lung cancer with negative biopsy or awaiting further investigation
- Pneumonia confirmed by clinical or radiological diagnosis
- Non-malignant airway diseases such as asthma or COPD
- Other non-malignant respiratory diseases including interstitial lung disease, bronchiectasis, or breathing pattern disorder
- Healthy controls with no known respiratory disease
- Availability of relevant diagnostic and demographic data (for retrospective participants)
- Previous participation in VICTORY or ExPeL studies allowed for retrospective data
- Willing and able to perform breath test using Inflammacheck device
- Willing to allow access to clinical data and imaging results
- Able to understand and communicate in English, with or without translator
You will not qualify if you...
- Active respiratory infection other than pneumonia (e.g., tuberculosis) at breath sampling
- Major thoracic surgery or lung resection within past six months
- Current or recent chemotherapy or radiotherapy for lung cancer at breath sampling (except retrospective pre-treatment cases)
- Severe cognitive impairment or communication barriers preventing consent or compliance
- Pregnancy or breastfeeding
- Active use of cannabis or recreational drugs altering breath composition
- Tobacco smoking or use of vaping/e-cigarettes within 12 hours before breath collection
- Recent systemic antibiotics or new corticosteroids within two weeks (not applicable to pneumonia patients)
- Any condition compromising safety or data integrity as judged by investigator
- Unable or unwilling to provide informed consent
- Unable to complete breath test due to physical or cognitive limitations
- Participation in other interventional trials affecting breath biomarkers
- Systemic lung cancer treatment prior to breath sampling (lung cancer group only)
- History of active cancer within past 12 months except confirmed lung cancer group
- Bronchoscopy or invasive respiratory procedure within past 48 hours
- Pneumonia with concurrent lung cancer, thoracic malignancy, or lung fibrosis
- Pneumonia with co-existing asthma or COPD only with principal investigator's discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for breath sampling and data collection
Duration - Up to study completion (anticipated 30 December 2026)
Participants provide breath samples using the Inflammacheck device and allow access to clinical and imaging data for analysis.
1 visit (in-person) for breath test and data collection
Duration - From first participant enrollment through study completion (anticipated 30 December 2026)
Participants' breath biomarker data and clinical information are analyzed to refine an AI-based diagnostic model.
No additional visits required; data analysis only
Trial Site Locations
Total: 1 location
1
Portsmouth Hospitals University NHS Trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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