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Breathalyzer for lung cancer? new study tests AI-Powered nodule detection

NCT ID NCT06518655

Diagnosis Sponsor: ChromX Health Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study is testing whether a breath test can accurately tell the difference between benign and malignant lung nodules. Researchers will analyze volatile organic compounds (VOCs) in the exhaled breath of 3,000 people with lung nodules. The goal is to develop an AI model that could one day help doctors diagnose lung cancer earlier and more safely.

What this could mean

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

Active substance
breath analysis (volatile organic compounds) via GC-MS and μGC-PID
What this could lead to
If successful, this could lead to a simple, non-invasive breath test to help doctors decide which lung nodules are cancerous without needing a biopsy.
What could go wrong
This is an early exploratory study. The breath test may not be accurate enough to replace current methods, and results may not apply to all types of nodules or patients.

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 3,000 people

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

Started

Jun 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

People who have pulmonary nodules with a large diameter between 5 mm and 30 mm on a CT scan within six months.

Ages

18 to 80 years

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: * 18-80 years old; * Pulmonary nodules were detected through low-dose spiral CT, chest CT conventional scan, or high-resolution thin-layer CT examination, with a maximum diameter of 5-30 mm, including solid nodules and ground glass nodules; * Patients require pulmonary nodule resection to define the type of nodule pathology; * The Patients have not yet used any drugs for tumor treatment; * Patients and/or family members are able to understand the research protocol and are willing to participate in this study, providing written informed consent. Exclusion Criteria: * The maximum diameter of pulmonary nodules is greater than 30 mm; * Patients are unable to determine the pathological diagnosis of pulmonary nodules after surgical resection or biopsy; * Patients with recurrent lung cancer; * Patients who have undergone lung transplantation or lobectomy; * Individuals who currently or have a history of malignant tumors; * Patients in the acute phase of inflammation or in need of intensive care in the above selected disease groups; * Individuals with severe liver and kidney dysfunction; * Mental illness patients (such as severe dementia, schizophrenia, severe depression, manic depressive psychosis, etc.); * Confirmed HIV patients; * Pregnant or lactating women; * Patients or family members are unable to understand the conditions and objectives of this study. * The patient is unwilling or unable to personally sign the informed consent form.

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm Multiple Pulmonary Nodules pulmonary coin lesion

As listed by the trial registrant

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

Lung cancer Pulmonary nodules, multiple Pulmonary nodules, solitary

How to take part

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

  1. The places running it

    15 sites. 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

  • First People's Hospital of Foshan

    RECRUITING

    Foshan, Guangdong, 528000, China

  • Guangzhou Development Zone Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Huangpu District Chinese Medicine Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Huangpu District Hongshan Street Community Health Service Center

    RECRUITING

    Guangzhou, Guangdong, China

  • Huangpu District Jiufo Street Community Health Service Center

    RECRUITING

    Guangzhou, Guangdong, China

  • Huangpu District Lianhe Street Second Community Health Service Center

    RECRUITING

    Guangzhou, Guangdong, China

  • Huangpu District Xinlong Town Central Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Huangpu District Yonghe Street Community Health Service Center

    RECRUITING

    Guangzhou, Guangdong, China

  • Liwan District Central Hospital

    RECRUITING

    Guangzhou, Guangdong, 510175, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, China

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Sichuan Cancer Hospital

    RECRUITING

    Chengdu, Sichuan, 610042, China

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510140, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.