Carcinoma, Lung Cancer, Lung Neoplasms, NSCLC
Conditions
Keywords
volatile organic compounds, exhaled breath, biomarker
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTBreath test
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).
Sponsors
Beijing Haidian Hospital
Aerospace 731 Hospital
Beijing Breatha Biological Technology Co., Ltd, Beijing
The First Affiliated Hospital of Zhengzhou University
Jiangsu Cancer Institute & Hospital
Peking University People's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic sensitivity of exhaled breath | 2 year | Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of exhaled breath will be calculated |
| Diagnostic specificity of exhaled breath | 2 year | Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of exhaled breath will be calculated |
| Positive predictive value of exhaled breath | 2 year | Using pathologic diagnosis of lung cancer as gold standard, positive predictive value of exhaled breath will be calculated |
| Negative predictive value of exhaled breath | 2 year | Using pathologic diagnosis of lung cancer as gold standard, negative predictive value of exhaled breath will be calculated |
| Diagnostic accuracy of exhaled breath | 2 year | Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of exhaled breath will be calculated |
Countries
China
Outcome results
None listed