A Study Measuring Markers of Airway Inflammation in Breath Samples From People With Respiratory Diseases and Healthy Volunteers. (VICTORY 2)

May 5, 2026 updated by: Portsmouth Hospitals NHS Trust

An Expanded inVestigation of Inflammacheck™ to Measure Exhaled Breath CondensaTe Hydrogen perOxide in RespiratorY Conditions A Cross-sectional, Observational Study Comparing Exhaled Breath Biomarkers Across Respiratory Diseases and Healthy Volunteers.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Eligible patients will be identified by members of the clinical or research team during attendance at relevant hospital or community clinics, including:

  • Suspected lung cancer clinics and respiratory outpatient services
  • CT imaging lists for patients awaiting percutaneous CT lung biopsy
  • Inpatient wards with respiratory or pneumonia admissions; and
  • Community diagnostic hubs or screening services such as Total Lung Health Check.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy
12 healthy controls
Other: No intervention
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.
Lung cancer
11 people with lung cancer (all stages)
Other: No intervention
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.
Suspected lung cancer
71 people with suspected lung cancer (but a negative biopsy)
Other: No intervention
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.
Pneumonia
• 46 people with pneumonia
Other: No intervention
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.

What is the study measuring?

Primary Outcome Measures

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

To develop and refine an AI-based diagnostic model using Inflammacheck® breath biomarker data from a diversified cohort to reliably distinguish participants with lung cancer from those with non-malignant respiratory conditions and healthy controls.

Primary Endpoint: An AI model with diagnostic performance (Area Under the Receiver Operating Characteristic Curve (AUROC) target value of ≥0.80) that discriminates lung cancer from non-malignant respiratory conditions and healthy controls.
From first participant enrollment through study completion (anticipated 30 December 2026).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portsmouth Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/SC/0392

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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