Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath

Plain-language summary

This study investigates whether benign and malignant pulmonary nodules can be distinguished by analyzing volatile organic compounds in a person's exhaled breath. It enrolls patients aged 18-80 with a 5-30 mm pulmonary nodule detected on CT who require surgery to determine the nodule type. It is a study with no assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

ChromX Health

Intervention

Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system

Start date

6/30/2024

Estimated completion

6/30/2027

Countries

China

Related genes

Locations

• Beijing, China
• Foshan, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Wuhan, China
• Shanghai, China
• Chengdu, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.