Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath
Recruiting · NCT06518655 · Observational (researchers observe without assigning treatment) · Lead sponsor: ChromX Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) markers. This model aims to accurately differentiate benign from malignant nodules in individuals harboring pulmonary nodules. The primary objectives it strives to accomplish are: 1. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in distinguishing benign and malignant pulmonary nodules. 2. To evaluate the diagnostic effectiveness of an AI model that employs exhaled breath VOC biomakers to identify specific types of malignant nodules, including lung adenocarcinoma, lung squamous cell carcinoma, and small cell lung cancer. 3. To explore and identify key characteristic VOCs combinations that are associated with EGFR site mutations in malignant nodules, further modeling and evaluating the classification performance. By utilizing this comprehensive approach, the study hopes to contribute significantly to early detection and accurate classification of pulmonary nodules, ultimately leading to improved patient care and treatment outcomes.
Who can take part
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 is running
15 locations listed.
- Peking Union Medical College Hospital - Beijing, Beijing Municipality, China
- First People's Hospital of Foshan - Foshan, Guangdong, China
- The First Affiliated Hospital of Guangzhou Medical University - Guangzhou, Guangdong, China
- Liwan District Central Hospital - Guangzhou, Guangdong, China
- Guangzhou Development Zone Hospital - Guangzhou, Guangdong, China
- Huangpu District Chinese Medicine Hospital - Guangzhou, Guangdong, China
- Huangpu District Hongshan Street Community Health Service Center - Guangzhou, Guangdong, China
- Huangpu District Jiufo Street Community Health Service Center - Guangzhou, Guangdong, China
- Huangpu District Lianhe Street Second Community Health Service Center - Guangzhou, Guangdong, China
- Huangpu District Xinlong Town Central Hospital - Guangzhou, Guangdong, China
- Huangpu District Yonghe Street Community Health Service Center - Guangzhou, Guangdong, China
- The Fifth Affiliated Hospital of Guangzhou Medical University - Guangzhou, Guangdong, China
- Renmin Hospital of Wuhan University - Wuhan, Hubei, China
- Shanghai Chest Hospital - Shanghai, Shanghai Municipality, China
- Sichuan Cancer Hospital - Chengdu, Sichuan, China