NCT06518655Recruiting
Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath
Exploratory Study on the Identification of Benign and Malignant Pulmonary Nodules Using Volatile Organic Compounds in Human Exhaled Breath
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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: 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 19 Jul 2024
- Start date
- 30 Jun 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- ChromX Health
- Diseases
- Lung cancer
- NCT number
- NCT06518655
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 30 Jun 2024 to the primary completion date, 30 Dec 2026
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients are unable to determine the pathological diagnosis of pulmonary nodules after surgical resection or biopsy;
- Patients who have undergone lung transplantation or lobectomy;
Other illness
- Patients with recurrent lung cancer;
- 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;
- Mental illness patients (such as severe dementia, schizophrenia, severe depression, manic depressive psychosis, etc.);
- Confirmed HIV patients;
- Patients or family members are unable to understand the conditions and objectives of this study.
Other
- The maximum diameter of pulmonary nodules is greater than 30 mm;
- Individuals with severe liver and kidney dysfunction;
- Pregnant or lactating women;
- The patient is unwilling or unable to personally sign the informed consent form.
Who the study is looking for
- 18-80 years old;
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| First People's Hospital of Foshan Coordinator of this site? Confirm its status | Foshan | China | Recruiting |
| Huangpu District Chinese Medicine Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Huangpu District Jiufo Street Community Health Service Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Huangpu District Xinlong Town Central Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Huangpu District Lianhe Street Second Community Health Service Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Huangpu District Yonghe Street Community Health Service Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangzhou Development Zone Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Huangpu District Hongshan Street Community Health Service Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Liwan District Central Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Fifth Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.