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

ChromX Health

Status: Enrolling

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

Treatments: Other: Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06528418

MLD001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or females, age must be 18 years old or above.
• Patients must meet the CT imaging diagnostic criteria for different lung diseases, and patients must be able to provide electronic versions of CT image data.
• Patients must have a clear clinical diagnosis.
• All participants must sign a written informed consent form.

Exclusion criteria

• Pregnant women.
• Individuals with a history of cancer other than lung disease.
• Individuals who have undergone organ transplants or non-autologous (allogeneic) bone marrow or stem cell transplants.
• Individuals with other severe organic diseases or mental illnesses.
• Individuals with metabolic diseases such as diabetes, hyperlipidemia, etc.
• Any other condition that researchers deem unsuitable for participation in this clinical trial.

Trial design

10,000 participants in 2 patient groups

pulmonary disease

Description:

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 .

Treatment:

Other: Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system

normal individual

Description:

Individuals with no abnormalities detected in lung CT imaging.

Treatment:

Other: Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system