ClinicaliQ Trial Snapshot
- A Study Measuring Markers of Airway Inflammation in Breath Samples From People With Respiratory Diseases and Healthy Volunteers. — Recruiting • Oncology • NCT07426718.
- What is being tested: Non-invasive measurement of airway inflammation markers in breath samples to develop a potential screening tool for lung cancer, comparing patients with respiratory diseases and healthy volunteers.
- Patient eligibility overview: Study includes individuals at risk of lung cancer, those with existing respiratory diseases (such as COPD or asthma), and healthy control volunteers to establish baseline inflammatory markers across different populations.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : - 1. Age: Adults aged ≥18 years. 2. Consent: Willing and able to provide written informed consent (prospective participants only). 3. Clinical status: Belong to one of the defined diagnostic categories listed below: 1. Group A: Lung cancer confirmed by multidisciplinary team (MDT) diagnosis. 2. Group B: Suspected lung cancer (biopsy negative or awaiting further investigation). 3. Group C: Pneumonia (radiologically or clinically confirmed). 4. Group D: Non-malignant airways diseases (asthma or COPD). 5. Group E: Other non-malignant respiratory diseases (interstitial lung disease, bronchiectasis, breathing pattern disorder). 6. Group F: Healthy controls with no known respiratory disease. 4. Clinical documentation: Availability of relevant diagnostic and demographic data to confirm disease classification (for retrospective participants). 5. Previous participation: Individuals previously enrolled in the VICTORY or ExPeL studies may be included for retrospective data integration. 6. Willing and able to perform a breath test using the Inflammacheck® device. 7. Willing to allow access to relevant clinical data and imaging results 8. Be able to understand and communicate in English with or without the need for a translator, to ensure informed consent and comprehension of study procedures
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.