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

NCT06518655 | Recruiting

• 1 other identifier: LCLN01
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 15

Brief 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. 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. 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. 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.

Conditions

Pulmonary Nodules, Multiple; Pulmonary Nodules, Solitary; Lung Cancer

Keywords

Pulmonary Nodules; Lung Cancer; Volatile Organic Compounds; Human Exhaled Breath

Outcome Measures

Primary Outcomes (1)

• The diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in distinguishing benign and malignant pulmonary nodules.

  The diagnostic performance of the exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model will be compared with pathologic diagnosis and CT/LDCT data, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).

  3 years

Secondary Outcomes (1)

• The diagnostic effectiveness of an AI model to identify specific types of malignant nodules, including lung adenocarcinoma, lung squamous cell carcinoma, and small cell lung cancer.

  3 years

Other Outcomes (1)

• Establish an exhaled breath VOC model for predicting EGFR mutations in malignant pulmonary nodules.

  3 years

Study Arms (1)

Pulmonary Nodules

Pre-surgery adult patients with pulmonary nodule found by CT scan.

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

Interventions

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

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

Pulmonary Nodules

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People who have pulmonary nodules with a large diameter between 5 mm and 30 mm on a CT scan within six months.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Individuals who currently or have a history of malignant tumors;
• Patients in the acute phase of inflammation or in need of intensive care in the above 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 of this study.
• The patient is unwilling or unable to personally sign the informed consent form.

Sponsors & Collaborators

• First People's Hospital of Foshan: 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
• ChromX Health: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator

Study Sites (15)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510140, China

RECRUITING

Liwan District Central Hospital

Guangzhou, Guangdong, 510175, China

RECRUITING

Guangzhou Development Zone Hospital

Guangzhou, Guangdong, China

RECRUITING

Huangpu District Chinese Medicine Hospital

Guangzhou, Guangdong, China

RECRUITING

Huangpu District Hongshan Street Community Health Service Center

Guangzhou, Guangdong, China

RECRUITING

Huangpu District Jiufo Street Community Health Service Center

Guangzhou, Guangdong, China

RECRUITING

Huangpu District Lianhe Street Second Community Health Service Center

Guangzhou, Guangdong, China

RECRUITING

Huangpu District Xinlong Town Central Hospital

Guangzhou, Guangdong, China

RECRUITING

Huangpu District Yonghe Street Community Health Service Center

Guangzhou, Guangdong, China

RECRUITING

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610042, China

RECRUITING

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Volatile Organic Compounds in Human Exhaled Breath

MeSH Terms

Conditions

Multiple Pulmonary Nodules; Solitary Pulmonary Nodule; Lung Neoplasms

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Jianxing He, MD

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Hengrui Liang, MD

CONTACT

+86 15625064712; hengrui_liang@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 24, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)