A breath sniff could one day screen for lung cancer and more

NCT ID NCT07804017

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

Researchers are testing whether an electronic nose that analyzes exhaled breath can serve as a noninvasive prescreening tool for several diseases at once. The study plans to enroll up to 20,000 adults and will first standardize the breath-sampling procedure, then evaluate how well the device's risk models detect lung cancer, significant pulmonary nodules, chronic respiratory diseases, and metabolic or endocrine conditions. Participants provide breath samples alongside routine care, and results are for research only, not shared with clinicians or used to guide treatment.

What this could mean

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

Active substance
Electronic-nose breath analysis, a diagnostic test that measures patterns of gases in exhaled breath
What this could lead to
If it works, this could lead to a simple, noninvasive breath test to flag early signs of lung cancer, chronic lung disease, and metabolic conditions during routine checkups.
What could go wrong
This is an early, observational study. The test is for research only, not for diagnosis, and may not prove accurate enough for real-world screening across different devices and centers.

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 20,000 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Adults aged ≥18 years will be prospectively recruited from participating hospitals and health examination centers. The study population will include individuals undergoing routine health examinations, opportunistic screening, or planned disease-specific screening or clinical evaluation. Clinically stable volunteers will be enrolled in the methodological standardization cohort, while the multi-disease risk prescreening cohort will include consecutively recruited intended-use populations with available routine reference screening or sufficient clinical information for reference-status determination. Patients with suspected or confirmed disease may also be included for model development or exploratory analyses but will not replace the intended-use population for locked external evaluation.

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: Age ≥18 years. Able to provide informed consent and willing to sign written informed consent. Able to understand and follow standardized breathing instructions and safely complete seated exhaled-breath sampling. Breath sampling is considered by the study physician not to delay or interfere with necessary routine clinical care or health examination. Routine reference screening results are available for at least one prespecified disease module, or sufficient clinical information is available to determine the corresponding reference status. Willing to permit authorized study personnel to review relevant medical records and follow-up information within the scope of ethical approval. Exclusion Criteria: Refusal to participate, inability to provide valid informed consent, or inability to reliably comply with study procedures. Acute respiratory distress, active massive hemoptysis, untreated pneumothorax, significant impairment of consciousness, or any condition for which forced exhalation is considered unsafe by the study physician. Requirement for strict airborne isolation when the study site or equipment cannot meet applicable infection-control requirements. Recent major surgery, invasive procedure, or other clinical intervention for which the treating physician considers breath sampling should be postponed. Vomiting, severe nausea, intense coughing, or other conditions before sampling that substantially increase the risk of aspiration, syncope, or related adverse events. Acute oral or nasopharyngeal conditions, or recent food intake, smoking, alcohol consumption, vigorous exercise, or other factors that prevent standardized breath sampling; such participants may be rescheduled rather than permanently excluded. Key reference-standard information is unavailable and is not expected to be obtained through routine follow-up. Any other condition considered by the investigator to make participation inappropriate.

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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

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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