Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath
NCT ID: NCT06518655
Last Updated: 2025-12-24
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
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RECRUITING
3000 participants
OBSERVATIONAL
2024-06-30
2027-06-30
Brief Summary
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1. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in distinguishing benign and malignant pulmonary nodules.
2. To evaluate the diagnostic effectiveness of an AI model that employs exhaled breath VOC biomakers to identify specific types of malignant nodules, including lung adenocarcinoma, lung squamous cell carcinoma, and small cell lung cancer.
3. To explore and identify key characteristic VOCs combinations that are associated with EGFR site mutations in malignant nodules, further modeling and evaluating the classification performance.
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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pulmonary Nodules
Pre-surgery adult patients with pulmonary nodule found by CT scan.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Pulmonary nodules were detected through low-dose spiral CT, chest CT conventional scan, or high-resolution thin-layer CT examination, with a maximum diameter of 5-30 mm, including solid nodules and ground glass nodules;
* Patients require pulmonary nodule resection to define the type of nodule pathology;
* The Patients have not yet used any drugs for tumor treatment;
* Patients and/or family members are able to understand the research protocol and are willing to participate in this study, providing written informed consent.
Exclusion Criteria
* Patients are unable to determine the pathological diagnosis of pulmonary nodules after surgical resection or biopsy;
* Patients with recurrent lung cancer;
* Patients who have undergone lung transplantation or lobectomy;
* Individuals who currently or have a history of malignant tumors;
* Patients in the acute phase of inflammation or in need of intensive care in the above selected disease groups;
* Individuals with severe liver and kidney dysfunction;
* Mental illness patients (such as severe dementia, schizophrenia, severe depression, manic depressive psychosis, etc.);
* Confirmed HIV patients;
* Pregnant or lactating women;
* Patients or family members are unable to understand the conditions and objectives of this study.
* The patient is unwilling or unable to personally sign the informed consent form.
18 Years
80 Years
ALL
Yes
Sponsors
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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
Renmin Hospital of Wuhan University
OTHER
ChromX Health
INDUSTRY
Responsible Party
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Principal Investigators
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Jianxing He, MD
Role: STUDY_CHAIR
The First Affiliated Hospital of Guangzhou Medical University
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
First People's Hospital of Foshan
Foshan, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Liwan District Central Hospital
Guangzhou, Guangdong, China
Guangzhou Development Zone Hospital
Guangzhou, Guangdong, China
Huangpu District Chinese Medicine Hospital
Guangzhou, Guangdong, China
Huangpu District Hongshan Street Community Health Service Center
Guangzhou, Guangdong, China
Huangpu District Jiufo Street Community Health Service Center
Guangzhou, Guangdong, China
Huangpu District Lianhe Street Second Community Health Service Center
Guangzhou, Guangdong, China
Huangpu District Xinlong Town Central Hospital
Guangzhou, Guangdong, China
Huangpu District Yonghe Street Community Health Service Center
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Qian Wang, MD
Role: primary
Zhuxing Chen
Role: primary
Hengrui Liang, MD
Role: primary
Hengrui Liang, MD
Role: primary
Hengrui Liang, MD
Role: primary
Hengrui Liang, MD
Role: primary
Hengrui Liang, MD
Role: primary
Hengrui Liang, MD
Role: primary
Hengrui Liang, MD
Role: primary
Hengrui Liang, MD
Role: primary
Hengrui Liang, MD
Role: primary
Hengrui Liang, MD
Role: primary
Huiqing Lin, MD
Role: primary
Yanwei Zhang, MD
Role: primary
Bo Tian, MD
Role: primary
References
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Bousamra M 2nd, Schumer E, Li M, Knipp RJ, Nantz MH, van Berkel V, Fu XA. Quantitative analysis of exhaled carbonyl compounds distinguishes benign from malignant pulmonary disease. J Thorac Cardiovasc Surg. 2014 Sep;148(3):1074-80; discussion 1080-1. doi: 10.1016/j.jtcvs.2014.06.006. Epub 2014 Jun 8.
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Other Identifiers
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LCLN01
Identifier Type: -
Identifier Source: org_study_id