Actively Recruiting

Age: 18Years - 100Years
All Genders
Healthy Volunteers
ID06528418

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

Led by ChromX Health · Updated on 2025-03-26

10000

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

C

ChromX Health

Lead Sponsor

T

The First Affiliated Hospital of Guangzhou Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how to use exhaled breath volatile organic compound (VOC) markers and artificial intelligence (AI) to diagnose multiple lung diseases. This observational study aims to develop an advanced AI model that helps identify various common and additional pulmonary diseases, including lung cancer, infections, COPD, bronchitis, fibrosis, and others. Participants will provide breath samples analyzed by Gas chromatography-mass spectrometry (GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) systems. The study includes people with lung disease diagnosed by CT scans and clinical evaluation, as well as individuals with no lung abnormalities on CT imaging. This cross-sectional study plans to enroll up to 10,000 participants. During the study, breath samples and clinical data including CT results will be collected and analyzed to assess the AI model's accuracy in diagnosing lung diseases. The primary outcome is the model's diagnostic accuracy over two years. Participants may undergo clinical diagnosis reviews, CT exams, and breath testing. The study runs until mid-2027 and includes healthy volunteers aged 18 to 100 years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females, age must be 18 years old or above.
  • Patients must meet the CT imaging diagnostic criteria for different lung diseases and provide electronic CT image data.
  • Patients must have a clear clinical diagnosis.
  • All participants must sign a written informed consent form.
Not Eligible

You will not qualify if you...

  • Pregnant women.
  • Individuals with a history of cancer other than lung disease.
  • Individuals who have undergone organ transplants or non-autologous 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 deemed unsuitable by researchers.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single point in time during participation

Participants provide exhaled breath samples that are analyzed using Gas chromatography-mass spectrometry and micro Gas Chromatography-photoionisation detector systems to detect volatile organic compounds. Clinical diagnostic results, CT examination data, and clinical data are collected to evaluate pulmonary diseases.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants are observed over a period to assess the diagnostic accuracy of the exhaled breath VOC-assisted diagnostic artificial intelligence model for multiple pulmonary diseases.

Visits as needed for clinical follow-up during the 2 years

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510140

Actively Recruiting

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Research Team

H

Hengrui Liang, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.

GBD Chronic Respiratory Disease Collaborators

https://pubmed.ncbi.nlm.nih.gov/32526187

Clinical use of exhaled volatile organic compounds in pulmonary diseases: a systematic review.

Kim D G van de Kant, Linda J T M van der Sande, Quirijn Jöbsis...

https://pubmed.ncbi.nlm.nih.gov/23259710

Volatile organic compounds (VOC) in homes associated with asthma and lung function among adults in Northern Europe.

Juan Wang, Christer Janson, Thorarinn Gislason...

https://pubmed.ncbi.nlm.nih.gov/36690293