RecruitingNCT06518655

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


Sponsor

ChromX Health

Enrollment

3,000 participants

Start Date

Jun 30, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether chemicals in exhaled breath — called volatile organic compounds (VOCs) — can distinguish between benign (harmless) and malignant (cancerous) lung nodules. If effective, a simple breath test could help avoid unnecessary surgery for patients whose lung nodules turn out to be non-cancerous. **You may be eligible if...** - You are 18–80 years old - A CT scan has detected one or more lung nodules between 5 and 30 mm in size (solid or ground glass type) - Your doctors have recommended that the nodule be surgically removed to determine whether it is cancerous - You have not yet received any cancer treatments **You may NOT be eligible if...** - Your nodule is smaller than 5 mm or larger than 30 mm - You have already received cancer treatment - You are unable or unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Detection of volatile organic compound molecules in human exhaled breath by GC-MS and μGC-PID


Locations(15)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

First People's Hospital of Foshan

Foshan, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Liwan District Central Hospital

Guangzhou, Guangdong, China

Guangzhou Development Zone Hospital

Guangzhou, Guangdong, China

Huangpu District Chinese Medicine Hospital

Guangzhou, Guangdong, China

Huangpu District Hongshan Street Community Health Service Center

Guangzhou, Guangdong, China

Huangpu District Jiufo Street Community Health Service Center

Guangzhou, Guangdong, China

Huangpu District Lianhe Street Second Community Health Service Center

Guangzhou, Guangdong, China

Huangpu District Xinlong Town Central Hospital

Guangzhou, Guangdong, China

Huangpu District Yonghe Street Community Health Service Center

Guangzhou, Guangdong, China

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT06518655


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