Actively Recruiting
Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath
Led by ChromX Health · Updated on 2025-12-24
3000
Participants Needed
15
Research Sites
156 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
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.
CONDITIONS
Official Title
Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 80 years old
- Pulmonary nodules detected by CT scan, measuring 5 to 30 mm, including solid and ground glass nodules
- Requires pulmonary nodule surgery to determine pathology
- Has not used any tumor treatment drugs
- Able to understand the study and provide written informed consent
You will not qualify if you...
- Pulmonary nodules larger than 30 mm
- Unable to obtain pathological diagnosis after surgery or biopsy
- History of recurrent lung cancer
- Previous lung transplantation or lobectomy
- Current or past malignant tumors
- In acute inflammation phase or needing intensive care
- Severe liver or kidney dysfunction
- Mental illnesses such as severe dementia, schizophrenia, severe depression, or manic depressive psychosis
- Confirmed HIV infection
- Pregnant or breastfeeding women
- Unable to understand study conditions and objectives
- Unwilling or unable to sign informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
Actively Recruiting
3
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510140
Actively Recruiting
4
Liwan District Central Hospital
Guangzhou, Guangdong, China, 510175
Actively Recruiting
5
Guangzhou Development Zone Hospital
Guangzhou, Guangdong, China
Actively Recruiting
6
Huangpu District Chinese Medicine Hospital
Guangzhou, Guangdong, China
Actively Recruiting
7
Huangpu District Hongshan Street Community Health Service Center
Guangzhou, Guangdong, China
Actively Recruiting
8
Huangpu District Jiufo Street Community Health Service Center
Guangzhou, Guangdong, China
Actively Recruiting
9
Huangpu District Lianhe Street Second Community Health Service Center
Guangzhou, Guangdong, China
Actively Recruiting
10
Huangpu District Xinlong Town Central Hospital
Guangzhou, Guangdong, China
Actively Recruiting
11
Huangpu District Yonghe Street Community Health Service Center
Guangzhou, Guangdong, China
Actively Recruiting
12
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
13
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
14
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
15
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610042
Actively Recruiting
Research Team
H
Hengrui Liang, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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