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

Sponsor: Portsmouth Hospitals NHS Trust

NCT ID: NCT07426718

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
No intervention (other)
How long the study runs
Study runs about 9 months (dates as stated)
About the drug or intervention
No intervention — other: This is a multi-centre, mixed retrospective-prospective observational study with no intervention or randomisation.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at markers of inflammation in the lungs by testing breath samples from people with lung cancer, suspected lung cancer, pneumonia, other lung conditions, and healthy volunteers. The breath test uses a device called Inflammacheck®. The study is run by Portsmouth Hospitals NHS Trust.

Who can take part

  • Adults aged 18 or over
  • Able to give written informed consent
  • You fit one of the study groups: confirmed lung cancer; suspected lung cancer; pneumonia; asthma or COPD (chronic obstructive pulmonary disease); other non-cancerous lung conditions (interstitial lung disease, bronchiectasis, or a breathing pattern disorder); or healthy with no known lung disease
  • Able to do a breath test using the Inflammacheck® device
  • Happy for the team to look at your medical records and scan results
  • Able to understand and communicate in English, with or without a translator
  • People who took part in the VICTORY or ExPeL studies before may be included using their past data

Who may not be able to

  • A chest infection other than pneumonia (such as tuberculosis) at the time of the breath test
  • Major chest surgery or lung tissue removal in the past 6 months
  • Current or recent chemotherapy or radiotherapy for lung cancer at the time of the breath test
  • Severe memory or understanding problems, or anything that stops you giving consent or following the study steps
  • Pregnancy or breastfeeding
  • Current use of cannabis or recreational drugs that can change what is in your breath
  • Smoking, vaping, or e-cigarette use in the 12 hours before the breath test
  • Antibiotic tablets or injections, or a new course of steroid tablets or inhalers, in the past 2 weeks (this does not apply to people with pneumonia). Steady long-term steroid inhalers are allowed if the dose has not changed for at least 4 weeks
  • Any condition the study doctor thinks could affect your safety or the study data
  • Unable or unwilling to give informed consent, or unable to do the breath test
  • Currently taking part in another trial that could affect breath test results
  • Systemic treatment for lung cancer before the breath test (for the lung cancer group)
  • Any active cancer in the past 12 months (apart from some skin and cervical cancers), unless you are in the confirmed lung cancer group
  • A bronchoscopy or other invasive lung procedure in the past 48 hours
  • Pneumonia together with lung cancer, chest cancer, or lung fibrosis. Pneumonia with asthma or COPD may be allowed at the study doctor's discretion

What taking part involves

  • • Breathing into the Inflammacheck® device so a breath sample can be collected
  • • Allowing the study team access to your medical records and imaging results

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
140
Started
2026-03-05
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for lung cancer (diagnosis)
  • • Clinical study - 140 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with lung cancer (diagnosis)

Where?

  • • Portsmouth - Portsmouth Hospitals University NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Lung Cancer (Diagnosis)Lung Cancer (Suspected or Confirmed)HealthyPneumonia

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

biopsy negative

What the study is looking for

  • ✓\- 1. Age: Adults aged ≥18 years. 2. Consent: Willing and able to provide written agreement to take part (prospective...
  • ✓3\. Clinical status: Belong to one of the defined diagnostic categories listed below:
  • ✓Group A: Lung cancer confirmed by multidisciplinary team (MDT) diagnosis.
  • ✓Group B: Suspected lung cancer (biopsy negative or awaiting further investigation).
  • ✓Group C: Pneumonia (radiologically or clinically confirmed).

Who cannot take part

  • ✗1\. Active respiratory infection (e.g., tuberculosis, bronchopneumonia) other than pneumonia (e.g., tuberculosis) at...
  • ✗2\. History of major thoracic surgery or lung resection within the previous six months.
  • ✗3\. Current or recent drug treatment or radiotherapy for lung cancer at the time of breath sampling (except for...
  • ✗4\. Severe cognitive impairment, communication barriers, or any condition preventing agreement to take part or compliance...
  • ✗5\. Pregnancy or breastfeeding. 6. Active use of cannabis or recreational drugs known to alter exhaled breath...
See the full criteria
Inclusion Criteria: \- 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 Exclusion Criteria: * 1\. Active respiratory infection (e.g., tuberculosis, bronchopneumonia) other than pneumonia (e.g., tuberculosis) at the time of breath sampling. 2\. History of major thoracic surgery or lung resection within the previous six months. 3\. Current or recent chemotherapy or radiotherapy for lung cancer at the time of breath sampling (except for retrospective confirmed cancer cases where data were collected pre-treatment). 4\. Severe cognitive impairment, communication barriers, or any condition preventing informed consent or compliance with study procedures. 5\. Pregnancy or breastfeeding. 6. Active use of cannabis or recreational drugs known to alter exhaled breath composition. 7\. Current active tobacco smoking within the past 12 hours prior to breath collection will be an exclusion criterion, as will the use of vaping or e-cigarettes within this period, to prevent contamination of exhaled breath samples 8. Participants who have taken systemic antibiotics or commenced a new course of oral or inhaled corticosteroids within the preceding two weeks will also be excluded, as these may transiently alter inflammatory biomarkers in exhaled breath (this is not applicable to participants with pneumonia). Stable use of maintenance inhaled corticosteroids in patients with chronic respiratory conditions (e.g., asthma, COPD) will be permitted, provided dosing has remained unchanged for at least four weeks prior to sampling. 9\. Any condition that, in the opinion of the investigator, could compromise participant safety or the integrity of the data. 10\. Unable or unwilling to provide informed consent. 11. Unable to complete the breath test due to physical or cognitive limitations. 12\. Currently participating in another interventional clinical trial that may confound breath biomarker data. 13\. Received systemic treatment for lung cancer prior to breath sampling (for the lung cancer group only). 14\. History of any active cancer within the past 12 months (excluding basal cell carcinoma of the skin or cervical carcinoma in situ), except for those in the confirmed lung cancer group. 15\. They have any active respiratory infection other than pneumonia (e.g., tuberculosis) at the time of breath sampling. 16\. They have undergone a bronchoscopy or invasive respiratory procedure within the past 48 hours, due to the potential for artefacts in breath data. 17\. Pneumonia with concurrent lung cancer, thoracic malignancy or lung fibrosis. Pneumonia with co-existent asthma or COPD can be included at discretion of the PI.

Where Is This Study? (1 UK site)

Portsmouth Hospitals University NHS Trust

Portsmouth PO6 3LY, United Kingdom

Recruiting
Site contact (verified)
Data sourced from ClinicalTrials.gov · Last verified: 2026-05