Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath
NCT ID: NCT06528418
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
10000 participants
OBSERVATIONAL
2024-06-30
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exhaled Breath Metabolomic Biomarkers in the Acutely Breathless Patient
NCT03672994
Research on the Characteristics of Chronic Airway Diseases (asthma, COPD)
NCT06685315
Controls for Respiratory Diseases
NCT03120481
Respiratory Pathogens of Patients With Asthma and COPD Exacerbations
NCT02866357
Predictive Value of Inflammatory Biomarkers and FEV1 for COPD
NCT03532893
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 .
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
normal individual
Individuals with no abnormalities detected in lung CT imaging.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The First Affiliated Hospital of Guangzhou Medical University
OTHER
First People's Hospital of Foshan
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Liwan District Central Hospital
UNKNOWN
Shanghai Chest Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Guangzhou Development Zone Hospital
UNKNOWN
Huangpu District Hongshan Street Community Health Service Center
UNKNOWN
Huangpu District Chinese Medicine Hospital
UNKNOWN
Fifth Affiliated Hospital of Guangzhou Medical University
OTHER
Huangpu District Jiufo Street Community Health Service Center
UNKNOWN
Huangpu District Xinlong Town Central Hospital
UNKNOWN
Huangpu District Yonghe Street Community Health Service Center
UNKNOWN
Huangpu District Lianhe Street Second Community Health Service Center
UNKNOWN
ChromX Health
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jianxing He, MD
Role: STUDY_CHAIR
The First Affiliated Hospital of Guangzhou Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3.
Ratiu IA, Ligor T, Bocos-Bintintan V, Mayhew CA, Buszewski B. Volatile Organic Compounds in Exhaled Breath as Fingerprints of Lung Cancer, Asthma and COPD. J Clin Med. 2020 Dec 24;10(1):32. doi: 10.3390/jcm10010032.
van de Kant KD, van der Sande LJ, Jobsis Q, van Schayck OC, Dompeling E. Clinical use of exhaled volatile organic compounds in pulmonary diseases: a systematic review. Respir Res. 2012 Dec 21;13(1):117. doi: 10.1186/1465-9921-13-117.
Wang J, Janson C, Gislason T, Gunnbjornsdottir M, Jogi R, Orru H, Norback D. Volatile organic compounds (VOC) in homes associated with asthma and lung function among adults in Northern Europe. Environ Pollut. 2023 Mar 15;321:121103. doi: 10.1016/j.envpol.2023.121103. Epub 2023 Jan 21.
V A B, Subramoniam M, Mathew L. Noninvasive detection of COPD and Lung Cancer through breath analysis using MOS Sensor array based e-nose. Expert Rev Mol Diagn. 2021 Nov;21(11):1223-1233. doi: 10.1080/14737159.2021.1971079. Epub 2021 Aug 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MLD001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.