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Simple breath test could revolutionize lung cancer screening

NCT ID NCT07426718

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device called Inflammacheck that measures chemicals in a person's breath to see if it can help tell the difference between lung cancer, other lung diseases, and healthy lungs. Researchers will collect breath samples from 140 adults and use AI to build a diagnostic model. If it works, this could become a quick, painless way to triage patients with breathing symptoms and catch lung cancer earlier.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a simple, non-invasive breath test to help doctors quickly identify who needs further testing for lung cancer, potentially catching more cases early.
What could go wrong
This is an early-stage observational study, not a treatment trial. The AI model may not perform as well in real-world settings, and the test is not yet proven to reduce deaths.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Portsmouth Hospitals University NHS Trust

    RECRUITING

    Portsmouth, Hampshire, PO6 3LY, United Kingdom

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