Detecting Lung Cancer Based on Exhaled Breath

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419207
• Other study ID #: 2019PHB095-01
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2236
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Lung Cancer
• Lung Neoplasms
• NSCLC

Intervention

Diagnostic Test:
• Breath 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-?ight mass spectrometry (HPPI-TOFMS).

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Peking University People's Hospital	Aerospace 731 Hospital, Beijing Breatha Biological Technology Co., Ltd, Beijing, Beijing Haidian Hospital, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic sensitivity of exhaled breath	Using pathologic diagnosis of lung cancer as gold standard, diagnostic sensitivity of exhaled breath will be calculated	2 year
Primary	Diagnostic specificity of exhaled breath	Using pathologic diagnosis of lung cancer as gold standard, diagnostic specificity of exhaled breath will be calculated	2 year
Primary	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
Primary	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
Primary	Diagnostic accuracy of exhaled breath	Using pathologic diagnosis of lung cancer as gold standard, diagnostic accuracy of exhaled breath will be calculated	2 year