Exploratory Study on the Identification of Benign and Malignant Pulmonary Nodules Using Volatile Organic Compounds in Human Exhaled Breath

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Other
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Sichuan Cancer Hospital
RECRUITING
Chengdu
First People's Hospital of Foshan
RECRUITING
Foshan
Guangzhou Development Zone Hospital
RECRUITING
Guangzhou
Huangpu District Chinese Medicine Hospital
RECRUITING
Guangzhou
Huangpu District Hongshan Street Community Health Service Center
RECRUITING
Guangzhou
Huangpu District Jiufo Street Community Health Service Center
RECRUITING
Guangzhou
Huangpu District Lianhe Street Second Community Health Service Center
RECRUITING
Guangzhou
Huangpu District Xinlong Town Central Hospital
RECRUITING
Guangzhou
Huangpu District Yonghe Street Community Health Service Center
RECRUITING
Guangzhou
Liwan District Central Hospital
RECRUITING
Guangzhou
The Fifth Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Shanghai Chest Hospital
RECRUITING
Shanghai
Contact Information
Primary
Hengrui Liang, MD
hengrui_liang@163.com
+86 15625064712
Time Frame
Start Date: 2024-06-30
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 3000
Treatments
Pulmonary Nodules
Pre-surgery adult patients with pulmonary nodule found by CT scan.
Sponsors
Collaborators: Shanghai Chest Hospital, Peking Union Medical College Hospital, The First Affiliated Hospital of Guangzhou Medical University, Huangpu District Xinlong Town Central Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, Huangpu District Hongshan Street Community Health Service Center, Huangpu District Jiufo Street Community Health Service Center, First People's Hospital of Foshan, Guangzhou Development Zone Hospital, Huangpu District Lianhe Street Second Community Health Service Center, Sichuan Cancer Hospital and Research Institute, Huangpu District Yonghe Street Community Health Service Center, Huangpu District Chinese Medicine Hospital, Liwan District Central Hospital
Leads: ChromX Health

This content was sourced from clinicaltrials.gov