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

Sponsor
Portsmouth Hospitals NHS Trust
Study ID
NCT07426718
Status
Recruiting
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Conditions

  • Healthy
  • Lung Cancer (Diagnosis)
  • Lung Cancer (Suspected or Confirmed)
  • Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • No intervention — OTHER
    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.

Study Details

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.

Key Dates

First listed
Feb 23, 2026
Start date
Mar 5, 2026
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
140 participants (estimated)

Arms

  • Arm: Healthy
    12 healthy controls
  • Arm: Lung cancer
    11 people with lung cancer (all stages)
  • Arm: Suspected lung cancer
    71 people with suspected lung cancer (but a negative biopsy)
  • Arm: Pneumonia
    • 46 people with pneumonia

Primary Outcome Measure

Refine an AI-based diagnostic model [ Time Frame: From first participant enrollment through study completion (anticipated 30 December 2026). ]

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