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

Sponsor
ChromX Health
Study ID
NCT06528418
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system — OTHER
    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

Study Details

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.

Key Dates

First listed
Jul 30, 2024
Start date
Jun 30, 2024
Status verified
Mar 2025
Primary completion
Dec 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: pulmonary disease
    Individuals with abnormalities in lung CT imaging and clinically diagnosed with 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 .
  • Arm: normal individual
    Individuals with no abnormalities detected in lung CT imaging.

Primary Outcome Measure

The diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in the diagnosis of several common pulmonary diseases. [ Time Frame: 2 years ]

Central Contacts

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