Detecting Lung Cancer Based on Exhaled Breath

Study Overview
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Brief Summary
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Early detection is critical to improve the overall survival of lung cancer. Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. On the other hand, cancer cells have different metabolism patterns compared with normal cells. Thus, detecting VOCs in exhaled breath using highly sensitive mass spectrometry would be a promising approach for lung cancer detection.

Detailed Description
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Endogenous volatile organic compounds (VOCs) can be derived from many different metabolic pathways. VOCs can be transported to the alveoli through the blood circulation and expelled by exhalation. Changes in VOCs production, clearance, and alterations in lung air-blood exchange functions can lead to aberrant VOCs profiles in the exhaled breath. Testing exhaled breath has the advantages of being completely non-invasive and easy to collect, and has been considered as a perfect approach for disease diagnoses and therapeutic monitoring. Many clinical studies have found that VOCs in exhaled breath are closely related to disease status. Specific VOCs alterations have been identified in many tumors, especially lung cancer. In this study, we use a highly sensitive mass spectrometry to detect exhaled VOCs of lung cancer patients and healthy people. A lung cancer diagnosis model based on mass spectrometry data and support vector machine will be initially established and validated.

Official Title
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Detecting Lung Cancer by Volatile Organic Compounds in Exhaled Breath: a Study of Lung Cancer Diagnostic Biomarker

Conditions
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Carcinoma, Lung Cancer, NSCLC, Lung Neoplasms

Intervention / Treatment
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* Diagnostic Test: Breath test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for inpatient : pulmonary nodules in competed tomography images plan to receive thoracic surgery Inclusion Criteria for controls : have planned physical examination every year plan to receive low-dose computed tomography Exclusion Criteria: history of malignant tumors. receive anti-tumor treatment such as radiotherapy, chemotherapy, targeted therapy before surgery with infections or liver disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Surbery<br>Patients who with pulmonary nodules in computed tomography and planned to receive thoracic surgery will be included. And those who have other types of cancer, received anti-tumor treatment before surgery, liver disease, or infections will be excluded. | Diagnostic Test: Breath test<br>* Exhaled breath of each participant will be collected with air bags and directly detected by a high-resolution high-pressure photon ionization time-of-ﬂight mass spectrometry (HPPI-TOFMS).<br>|
| Healthy Controls<br>Adult participants (>18 yr) who plan to receive annual physical examination and low-dose computed tomography will be included. And those who have history cancers, received anti-tumor treatment before surgery, liver disease, or infections will be excluded. | Diagnostic Test: Breath test<br>* Exhaled breath of each participant will be collected with air bags and directly detected by a high-resolution high-pressure photon ionization time-of-ﬂight mass spectrometry (HPPI-TOFMS).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic sensitivity of exhaled breath | Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of exhaled breath will be calculated | 2 year | 
| Diagnostic specificity of exhaled breath | Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of exhaled breath will be calculated | 2 year | 
| Positive predictive value of exhaled breath | Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of exhaled breath will be calculated | 2 year | 
| Negative predictive value of exhaled breath | Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of exhaled breath will be calculated | 2 year | 
| Diagnostic accuracy of exhaled breath | Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of exhaled breath will be calculated | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volatile organic compounds, exhaled breath, biomarker