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RECRUITING
NCT06518655

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

Sponsor: ChromX Health

View on ClinicalTrials.gov

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

OTHER

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