Using breath analysis to differentiate between benign and malignant lung nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• First People's Hospital of Foshan
  Foshan, Guangdong, China Recruiting
• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• Liwan District Central Hospital
  Guangzhou, Guangdong, China Recruiting
• Guangzhou Development Zone Hospital
  Guangzhou, Guangdong, China Recruiting
• Huangpu District Chinese Medicine Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Hengrui Liang, MD
• Email: hengrui_liang@163.com
• Phone: +86 15625064712

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.