Lung Cancer (Diagnosis)VICTORY 2NCT07426718
A Study Measuring Markers of Airway Inflammation in Breath Samples From People With Respiratory Diseases and Healthy Volunteers.
An observational study of Lung Cancer (Diagnosis) and Lung Cancer (Suspected or Confirmed), run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer (Diagnosis), Lung Cancer (Suspected or Confirmed), Healthy
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Mar 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
- 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).
- Group D: Non-malignant airways diseases (asthma or COPD).
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- Group E: Other non-malignant respiratory diseases (interstitial lung disease, bronchiectasis, breathing pattern disorder).
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Portsmouth Hospitals University NHS Trust
Portsmouth, Hampshire, PO6 3LY
Research Office, 02392286000 ext. 5153, pho-tr.researchoffice-groupmailbox@nhs.net
About this study
Official title: 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.
- Being tested
- No intervention
- Medical subject headings
- Lung Neoplasms, Disease, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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 group | Role | What they receive |
|---|---|---|
| Healthy | 12 healthy controls Receives: Other: No intervention | |
| Lung cancer | 11 people with lung cancer (all stages) Receives: Other: No intervention | |
| Suspected lung cancer | 71 people with suspected lung cancer (but a negative biopsy) Receives: Other: No intervention | |
| Pneumonia | • 46 people with pneumonia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refine an AI-based diagnostic model
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.
Measured: From first participant enrollment through study completion (anticipated 30 December 2026).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start5 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426718
- Sponsor's protocol ID
- 25/SC/0392
- Acronym
- VICTORY 2
- Status last verified
- May 2026
- First submitted
- 16 Feb 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07426718
- Acronym / sponsor ID
- VICTORY 2 / 25/SC/0392
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: No intervention12 healthy controls |
| Lung cancer | – | Other: No intervention11 people with lung cancer (all stages) |
| Suspected lung cancer | – | Other: No intervention71 people with suspected lung cancer (but a negative biopsy) |
| Pneumonia | – | Other: No intervention• 46 people with pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 1. Age: Adults aged ≥18 years. 2. Consent: Willing and able to provide written informed consent (prospective participants only).
- 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).
- Group D: Non-malignant airways diseases (asthma or COPD).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis 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. | Other | Healthy, Lung cancer, Pneumonia, Suspected lung cancer |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (Diagnosis) and Lung Cancer (Suspected or Confirmed), run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refine an AI-based diagnostic model (time frame: From first participant enrollment through study completion (anticipated 30 December 2026).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.