Status:
RECRUITING
Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath
Lead Sponsor:
ChromX Health
Collaborating Sponsors:
The First Affiliated Hospital of Guangzhou Medical University
First People's Hospital of Foshan
Conditions:
Pulmonary Nodules, Multiple
Pulmonary Nodules, Solitary
Eligibility:
All Genders
18-80 years
Brief Summary
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 ...
Detailed Description
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, exh...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- The maximum diameter of pulmonary nodules is greater than 30 mm;
- 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.
Key Trial Info
Start Date :
June 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06518655
Start Date
June 30 2024
End Date
June 30 2027
Last Update
December 24 2025
Active Locations (15)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
2
First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
3
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510140
4
Liwan District Central Hospital
Guangzhou, Guangdong, China, 510175