NCT06518655

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

Exploratory Study on the Identification of Benign and Malignant Pulmonary Nodules Using Volatile Organic Compounds in Human Exhaled Breath

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: ChromX Health · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a prospective, cross-sectional, and observational cohort study aiming at recruiting 3000 participants with pulmonary nodules ranging from 5 to 30 mm in diameter. Prior to invasive surgery, exhaled breath samples will be collected from these participants and analyzed using Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system. Following the acquisition of μGC-PID results, a comprehensive evaluation of the diagnostic performance of VOC biomakers distinguishing between benign and malignant pulmonary nodules will be conducted, leveraging histopathological findings, CT examination data, and clinical data.

Conditions

• Pulmonary Nodules, Multiple
• Pulmonary Nodules, Solitary
• Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-30
• Primary completion: 2026-12-30
• Completion: 2027-06-30
• First posted: 2024-07-24
• Last updated: 2025-12-24

Locations

15 sites across 1 country: China