An observational study in Pulmonary Nodules, Multiple, Pulmonary Nodules, Solitary and Lung Cancer, sponsored by ChromX Health. Recruiting at 15 sites in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by ChromX Health · Observational
The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) markers. This model aims to accurately differentiate benign from malignant nodules in individuals harboring pulmonary nodules. The primary objectives it strives to accomplish are:
By utilizing this comprehensive approach, the study hopes to contribute significantly to early detection and accurate classification of pulmonary nodules, ultimately leading to improved patient care and treatment outcomes.
This is a prospective, cross-sectional, and observational cohort study aiming at recruiting 3000 participants with pulmonary nodules ranging from 5 to 30 mm in diameter. Prior to invasive surgery, exhaled breath samples will be collected from these participants and analyzed using Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system. Following the acquisition of μGC-PID results, a comprehensive evaluation of the diagnostic performance of VOC biomakers distinguishing between benign and malignant pulmonary nodules will be conducted, leveraging histopathological findings, CT examination data, and clinical data.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 255 across 51 observational studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →ChromX Health is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
People who have pulmonary nodules with a large diameter between 5 mm and 30 mm on a CT scan within six months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pre-surgery adult patients with pulmonary nodule found by CT scan.
Other: Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system
Detection of volatile organic compound molecules in human exhaled breath by GC-MS and μGC-PID
The diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in distinguishing benign and malignant pulmonary nodules.
The diagnostic performance of the exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model will be compared with pathologic diagnosis and CT/LDCT data, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
Time frame: 3 years
The diagnostic effectiveness of an AI model to identify specific types of malignant nodules, including lung adenocarcinoma, lung squamous cell carcinoma, and small cell lung cancer.
The diagnostic performance of the exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model will be compared with pathologic diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
Time frame: 3 years
Establish an exhaled breath VOC model for predicting EGFR mutations in malignant pulmonary nodules.
Establish an exhaled breath VOC model for predicting EGFR mutations in pathologically confirmed malignant pulmonary nodules. And evaluate the prediction accuracy by comparing the results of EGFR gene testing.
Time frame: 3 years
Plan to share: No
Started Jun 2024 (actual). Primary completion is estimated for Dec 2026, 30 months after the start.
Of 24 observational studies under Multiple Pulmonary Nodules, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 62. This study's planned 30 months is below that.
How these figures are worked out, and which studies are left out of them.
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