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Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath
Sponsor: ChromX Health
Summary
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.
Official title: Exploratory Study on the Identification of Benign and Malignant Pulmonary Nodules Using Volatile Organic Compounds in Human Exhaled Breath
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
3000
Start Date
2024-06-30
Completion Date
2027-06-30
Last Updated
2025-12-24
Healthy Volunteers
Yes
Interventions
Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system
Detection of volatile organic compound molecules in human exhaled breath by GC-MS and μGC-PID
Locations (15)
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