Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorChromX Health

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system

Treatment groups

3,000 Participants
are divided into 1 treatment group

Sponsors and collaborators

ChromX Health

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Collaborator

First People's Hospital of Foshan

Collaborator

Sichuan Cancer Hospital and Research Institute

Collaborator

Liwan District Central Hospital

Collaborator

Shanghai Chest Hospital

Collaborator

Peking Union Medical College Hospital

Collaborator

Guangzhou Development Zone Hospital

Collaborator

Huangpu District Hongshan Street Community Health Service Center

Collaborator

Huangpu District Chinese Medicine Hospital

Collaborator

Fifth Affiliated Hospital of Guangzhou Medical University

Collaborator

Huangpu District Jiufo Street Community Health Service Center

Collaborator

Huangpu District Xinlong Town Central Hospital

Collaborator

Huangpu District Yonghe Street Community Health Service Center

Collaborator

Huangpu District Lianhe Street Second Community Health Service Center

Collaborator

Renmin Hospital of Wuhan University

Collaborator