NCT06528418

Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath

Exploration and Study on the Identification of Various Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: ChromX Health · Industry
• Sex: All
• Age: 18 Years – 100 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) marker molecules. This model aims to accurately diagnose mutiple pulmonary diseases. 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 diagnose several common pulmonary diseases. 2. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose more pulmonary diseases.

Detailed description

This is a prospective, cross-sectional, observational cohort study aimed at recruiting 10,000 participants with multiple pulmonary disease, including lung cancer, lung infection, chronic obstructive pulmonary disease (COPD), bronchitis, pulmonary fibrosis, pulmonary embolism, pulmonary arterial hypertension, tuberculosis, lung abscess, emphysema, radioactive lung injury, cystic fibrosis of the lung, Bronchial Asthma, Bronchiectasis, interstitial lung disease (ILD), preserved ratio impaired spirometry (PRISm) etc . Exhaled breath samples from these participants will be collected and analyzed using Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system. Upon obtaining the μGC-PID results, a comprehensive evaluation of the diagnostic capabilities of exhaled breath samples in differentiating various pulmonary diseases will be performed, leveraging clinical diagnostic results, CT examination data, and clinical data.

Conditions

• Lung Cancer
• Lung Infection
• COPD
• Bronchitis
• Pulmonary Fibrosis
• Pulmonary Embolism
• Pulmonary Arterial Hypertension
• Pulmonary Tuberculosis
• Pulmonary Abscess
• Emphysema
• Lung Injury
• Cystic Fibrosis of the Lung
• Bronchial Asthma
• Bronchiectasis
• Interstitial Lung Disease
• Preserved Ratio Impaired Spirometry

Interventions

Type	Name	Description
OTHER	Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system	Exhaled breath samples from these participants will be collected and analyzed to detect 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: 2024-07-30
• Last updated: 2025-03-26

Locations

1 site across 1 country: China