Home › Trials › NCT06518655

Using breath analysis to differentiate between benign and malignant lung nodules

Exploratory Study on the Identification of Benign and Malignant Pulmonary Nodules Using Volatile Organic Compounds in Human Exhaled Breath

Observational ChromX Health · NCT06518655

This study is testing whether analyzing breath samples can help tell the difference between harmless and cancerous lung nodules in people who have been diagnosed with them.

Quick facts

Study typeObservational
Enrollment3000 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorChromX Health Industry-sponsored
Locations15 sites (Beijing, Beijing Municipality and 14 other locations)
Trial IDNCT06518655 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop an advanced algorithm that utilizes volatile organic compounds (VOCs) found in exhaled breath to differentiate between benign and malignant pulmonary nodules. It will recruit 3000 participants with nodules detected via CT scans, collecting breath samples prior to any surgical intervention. The study will analyze these samples using sophisticated techniques like gas chromatography-mass spectrometry and evaluate the diagnostic performance of the VOC biomarkers against histopathological findings. The ultimate goal is to enhance the accuracy of lung cancer diagnosis and identify specific types of malignant nodules.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with pulmonary nodules between 5-30 mm detected by CT scans who require surgical resection for diagnosis.

Not a fit: Patients with nodules larger than 30 mm, recurrent lung cancer, or those who have undergone lung transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a non-invasive method for accurately diagnosing lung cancer, potentially improving patient outcomes.

How similar studies have performed: While the use of VOCs in breath analysis is a novel approach, similar studies have shown promise in differentiating between types of lung cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Beijing, Beijing Municipality and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Nodules, MultiplePulmonary Nodules, SolitaryLung CancerPulmonary NodulesVolatile Organic CompoundsHuman Exhaled Breath
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.