Exploration and Study on the Identification of Various Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath
Trial ID: NCT06528418
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2024-06-30
Completion date: 2027-06-30
Sponsor: ChromX Health
Collaborators: The First Affiliated Hospital of Guangzhou Medical University; First People's Hospital of Foshan; Sichuan Cancer Hospital and Research Institute; Liwan District Central Hospital; Shanghai Chest Hospital; Peking Union Medical College Hospital; Guangzhou Development Zone Hospital; Huangpu District Hongshan Street Community Health Service Center; Huangpu District Chinese Medicine Hospital; Fifth Affiliated Hospital of Guangzhou Medical University; Huangpu District Jiufo Street Community Health Service Center; Huangpu District Xinlong Town Central Hospital; Huangpu District Yonghe Street Community Health Service Center; Huangpu District Lianhe Street Second Community Health Service Center
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: Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system
Locations: The First Affiliated Hospital of Guangzhou Medical University
Countries: China
Enrollment: 10000
Age range: 18 Years - 100 Years
Sex: ALL

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.

Eligibility criteria:
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.

Outcomes:
The diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in the diagnosis of several common pulmonary diseases.