Actively Recruiting
A Study Measuring Markers of Airway Inflammation in Breath Samples From People With Respiratory Diseases and Healthy Volunteers.
Led by Portsmouth Hospitals NHS Trust · Updated on 2026-05-08
140
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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).
- Belong to one of the diagnostic groups: confirmed lung cancer, suspected lung cancer, pneumonia, asthma or COPD, other non-malignant respiratory diseases, or healthy controls.
- Availability of diagnostic and demographic data to confirm disease classification (for retrospective participants).
- Previous participants in VICTORY or ExPeL studies may be included for retrospective data.
- Willing and able to perform a breath test using the Inflammacheck device.
- Willing to allow access to clinical data and imaging results.
- Able to understand and communicate in English, with or without a 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 the past six months.
- Current or recent chemotherapy or radiotherapy for lung cancer at breath sampling (except pre-treatment retrospective cases).
- Severe cognitive impairment or communication barriers preventing consent or compliance.
- Pregnancy or breastfeeding.
- Active use of cannabis or recreational drugs affecting breath composition.
- Tobacco smoking, vaping, or e-cigarette use within 12 hours prior to breath collection.
- Systemic antibiotics or new corticosteroid use within two weeks prior to sampling (except for pneumonia patients).
- Conditions risking participant safety or data integrity per investigator judgment.
- Unable or unwilling to provide informed consent.
- Unable to complete breath test due to physical or cognitive limitations.
- Participation in another interventional trial that may affect breath biomarker data.
- Received systemic lung cancer treatment before breath sampling (lung cancer group only).
- History of active cancer within the past 12 months, except basal cell skin cancer or cervical carcinoma in situ (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 asthma or COPD may be included at investigator discretion.
AI-Screening
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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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