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

Last updated: March 23, 2025
Sponsor: ChromX Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Pulmonary Nodules

Non-small Cell Lung Cancer

Treatment

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

Clinical Study ID

NCT06518655
LCLN01
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 18-80 years old;

  • Pulmonary nodules were detected through low-dose spiral CT, chest CT conventionalscan, or high-resolution thin-layer CT examination, with a maximum diameter of 5-30mm, 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 arewilling to participate in this study, providing written informed consent.

Exclusion

Exclusion Criteria:

  • The maximum diameter of pulmonary nodules is greater than 30 mm;

  • Patients are unable to determine the pathological diagnosis of pulmonary nodulesafter 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 theabove 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 ofthis study.

  • The patient is unwilling or unable to personally sign the informed consent form.

Study Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system
Phase:
Study Start date:
June 30, 2024
Estimated Completion Date:
June 30, 2027

Study 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, exhaled breath samples will be collected from these participants and analyzed using Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system. Following the acquisition of μGC-PID results, a comprehensive evaluation of the diagnostic performance of VOC biomakers distinguishing between benign and malignant pulmonary nodules will be conducted, leveraging histopathological findings, CT examination data, and clinical data.

Connect with a study center

  • Peking Union Medical College Hospital

    Peking, Beijing
    China

    Active - Recruiting

  • First People's Hospital of Foshan

    Foshan, Guangdong 528000
    China

    Active - Recruiting

  • Guangzhou Development Zone Hospital

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Huangpu District Chinese Medicine Hospital

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Huangpu District Hongshan Street Community Health Service Center

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Huangpu District Jiufo Street Community Health Service Center

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Huangpu District Lianhe Street Second Community Health Service Center

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Huangpu District Xinlong Town Central Hospital

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Huangpu District Yonghe Street Community Health Service Center

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Liwan District Central Hospital

    Guangzhou, Guangdong 510175
    China

    Active - Recruiting

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510140
    China

    Active - Recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan 610042
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.